FDA product code · Microbiology
JSJCulture Media, Selective And Non-Differential
Product code JSJ covers Culture Media, Selective And Non-Differential, a Class I device regulated under 21 CFR 866.2360. FDA has cleared 307 devices in this code. Median review time across the 307 most recent decisions is 27 days. openFDA lists 6 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 866.2360
- Review panel
- Microbiology
- Clearances
- 307
What is happening in JSJ right now?
JSJ (Culture Media, Selective And Non-Differential) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1474-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1474-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JSJ?
FDA has cleared 307 devices under product code JSJ since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | Lakewood Biochemical Co., Inc. | |
| K881578 | STREPTOSEL | Acumedia Manufacturers, Inc. | |
| K881574 | W-L DIFFERENTIAL MEDIUM | Acumedia Manufacturers, Inc. | |
| K881573 | PHYTONE YEAST EXTRACT AGAR | Acumedia Manufacturers, Inc. | |
| K881571 | YM BROTH | Acumedia Manufacturers, Inc. | |
| K881570 | SABOURAUD MALTOSE AGAR | Acumedia Manufacturers, Inc. | |
| K881565 | INHIBITORY MOLD AGAR | Acumedia Manufacturers, Inc. | |
| K881561 | TERGITOL 7 BROTH | Acumedia Manufacturers, Inc. | |
| K881549 | MYCOLOGICAL AGAR W/LOW PH | Acumedia Manufacturers, Inc. | |
| K881547 | MITIS SALIVARIUS AGAR | Acumedia Manufacturers, Inc. |
How long does FDA review take for JSJ?
The median FDA review time for JSJ is 27 days, measured across the 307 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JSJ?
openFDA lists 6 recall records against product code JSJ. A recall record covers one firm's corrective action and may span many device lots.
Z-1474-2026Open, ClassifiedRemel, Inc.
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
Z-0284-2019TerminatedAcumedia Manufacturers, Inc.
The product is labeled with an incorrect expiration date.
Z-1571-2016TerminatedHardy Diagnostics
Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.
Z-1799-2013TerminatedBecton, Dickinson and Company
Microbiological identification media may exhibit reduced levels of Vancomycin.
Z-1800-2013TerminatedBecton, Dickinson and Company
Microbiological identification media may exhibit reduced levels of Vancomycin.
Showing the 5 most recently initiated of 6. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JSJ?
MAUDE holds 411 adverse-event reports naming product code JSJ, 75 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JSJ unusual?
JSJ does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 138 | Insufficient history | No expected range — too little history | |
| 187 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history |
24 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in JSJ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JSJ?
Across the 307 most recent decisions, these applicants filed most often in JSJ.
| Applicant | Recent clearances |
|---|---|
| Acumedia Manufacturers, Inc. | 30 |
| Lakewood Biochemical Co., Inc. | 30 |
| Hardy Media | 26 |
| Otisville Biotech, Inc. | 23 |
| Gibco Laboratories Life Technologies, Inc. | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JSJ
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.