FDA product code GNM: Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
GNM is the FDA product code for antisera, fluorescent, coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under GNM, from 2 different applicants. The average 510(k) review took 612 days (median 617).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 |
| Device class | Class I |
| Regulation | 21 CFR 866.3145 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNM clearance
Top GNM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chemicon Intl., Inc. | 5 | 1995-09-08 |
| Light Diagnostics | 4 | 1995-09-08 |
Most recent GNM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940471 | Chemicon Intl., Inc. | COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES | 1995-09-08 | 583 |
| K936145 | Chemicon Intl., Inc. | COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY | 1995-09-08 | 620 |
| K936254 | Light Diagnostics | COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY | 1995-09-08 | 617 |
| K940472 | Chemicon Intl., Inc. | COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY | 1995-09-08 | 583 |
| K936251 | Light Diagnostics | COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY | 1995-09-08 | 617 |
Recalls for GNM devices
openFDA lists no recalls for product code GNM.
Frequently asked questions
What is FDA product code GNM?
GNM is the FDA product code for antisera, fluorescent, coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel.
What device class is GNM?
Class I, regulation 21 CFR 866.3145. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNM?
Across 9 cleared submissions the average was 612 days from receipt to decision (median 617).
Which companies have the most GNM clearances?
Chemicon Intl., Inc. (5); Light Diagnostics (4).
Next steps
- Run an FDA pathway report with predicate devices for product code GNM
- Run a recall and safety report across every GNM manufacturer
- Watch product code GNM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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