Medical device manufacturer
Remel, Inc.
Remel, Inc. holds 154 FDA 510(k) clearances across 42 product codes. Median elapsed review time is 53 days. openFDA lists 113 recall records naming the company. FDA publishes it under 10 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 154
- Product codes
- 42
- Median review
- 53 days
- Recall records
- 113
How does FDA spell Remel, Inc.?
FDA publishes this company under 10 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| REMEL, INC. | device/registrationlisting | normalised |
| Remel Co. | device/510k | normalised |
| Remel Inc | device/enforcement | normalised |
| Remel Inc | device/recall | normalised |
| Remel Inc. | device/enforcement | normalised |
| Remel Inc. | device/recall | normalised |
| Remel, Inc | device/enforcement | normalised |
| Remel, Inc | device/recall | normalised |
Showing 8 of 10.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Remel, Inc. file in?
42 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 49 | 59 days | |
| JTN | Susceptibility Test Discs, Antimicrobial | 14 | 63 days | |
| JTS | Stains, Microbiologic | 12 | 51 days | |
| JSJ | Culture Media, Selective And Non-Differential | 11 | 39 days | |
| JSI | Culture Media, Selective And Differential | 9 | 29 days | |
| JSM | Culture Media, Non-Propagating Transport | 5 | 30 days | |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 5 | 179 days | |
| LIO | Device, Specimen Collection | 5 | 57 days | |
| JSF | Culture Media, Single Biochemical Test | 4 | 37 days | |
| JSN | Culture Media, Propagating Transport | 2 | 32 days | |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 2 | 31 days | |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 | 42 days | |
| JXB | Kit, Identification, Yeast | 2 | 89 days | |
| LLH | Reagents, Clostridium Difficile Toxin | 2 | 115 days | |
| MHI | Giardia Spp. | 2 | 147 days | |
| MJD | Culture Media, Antimycobacteria, Susceptibility Test | 2 | 17 days | |
| GNA | Antisera, All Types, Escherichia Coli | 1 | 280 days | |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 | 23 days | |
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | 1 | 39 days | |
| HYI | Iodine, Grams | 1 | 8 days | |
| IDC | Acridine Orange | 1 | 44 days | |
| IGB | Solution, Formalin-Sodium Acetate | 1 | 20 days | |
| JFO | Fluorometric, Calcium | 1 | 109 days | |
| JIO | Blood, Occult, Colorimetric, In Urine | 1 | 70 days | |
| JSD | Culture Media, Selective Broth | 1 | 30 days |
Showing the 25 they file in most, of 42.
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 Remel, Inc. had a recall?
openFDA lists 113 recall records naming this company across its whole history, of which 4 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2623-2026Class IIOpen, ClassifiedJTY
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Z-1806-2026Class IIOpen, ClassifiedNGZ
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Z-1474-2026Class IIOpen, ClassifiedJSJ
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
Z-0585-2026Class IIOpen, ClassifiedJTZ
Products may contain contamination, which may result in a darker or brown media color.
Z-2223-2025Class IIOpen, ClassifiedJSH
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Showing the 5 most recently initiated of 113.
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 Remel, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K162620 | Remel Spectra ESBL | JSO | 223 | |
| K131804 | REMEL XPECT FLU A&B | GNX | 23 | |
| K092407 | REMEL SPECTRA MRSA | JSO | 428 | |
| K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | MJE | 54 | |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | LLH | 118 | |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | LLH | 115 | |
| K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | MHI | 147 | |
| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | MHJ | 141 | |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | MHI | 150 | |
| K031565 | XPECT INFLUENZA A/B | PSZ | 59 |
Source: openFDA device/510k · retrieved
Where is Remel, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Remel, 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.