Medical device manufacturer
Difco Laboratories, Inc.
Difco Laboratories, Inc. holds 121 FDA 510(k) clearances across 34 product codes. Median elapsed review time is 38 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 121
- Product codes
- 34
- Median review
- 38 days
- Recall records
- 0
How does FDA spell Difco Laboratories, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Difco Laboratories, Inc. file in?
34 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 41 | 45 days | |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 34 | 25 days | |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 96 days | |
| JSF | Culture Media, Single Biochemical Test | 3 | 11 days | |
| JTW | System, Transport, Aerobic | 3 | 36 days | |
| KIR | Cells, Animal And Human, Cultured | 3 | 8 days | |
| MDB | System, Blood Culturing | 3 | 99 days | |
| LED | Stains, Chemical Solution | 2 | 8 days | |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 | 52 days | |
| DCN | System, Test, C-Reactive Protein | 1 | 36 days | |
| DHR | System, Test, Rheumatoid Factor | 1 | 16 days | |
| GMT | Antigens, Ha, Treponema Pallidum | 1 | 49 days | |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 95 days | |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 21 days | |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 53 days | |
| JNT | Chromatographic, Phospholipids | 1 | 51 days | |
| JSM | Culture Media, Non-Propagating Transport | 1 | 17 days | |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 | 90 days | |
| JTS | Stains, Microbiologic | 1 | 21 days | |
| JTT | Susceptibility Test Powders, Antimicrobial | 1 | 66 days | |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 21 days | |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 1 | 164 days | |
| JXA | Kit, Screening, Urine | 1 | 25 days | |
| KFC | Methylene Blue, Tissue Stain | 1 | 25 days | |
| KTN | System, Test, Infectious Mononucleosis | 1 | 17 days |
Showing the 25 they file in most, of 34.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Difco Laboratories, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Difco Laboratories, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K971211 | DISPENS-O-DISC SPARFLOXACIN | JTN | 18 | |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | JTN | 18 | |
| K963508 | DISPENS-O-DISC MEROPENEM | JTN | 23 | |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | JTW | 36 | |
| K954783 | DRYSLIDE CARTARRHALIS | JTO | 112 | |
| K954784 | DRYSIDE NEISSERIA | LTS | 105 | |
| K953129 | ESP CULTURE SYSTEM - MYCO | MDB | 173 | |
| K950706 | DRYSLIDE COAGULASE | JTL | 90 | |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | JTN | 111 | |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | JTO | 119 |
Source: openFDA device/510k · retrieved
Watch what Difco Laboratories, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.