FDA product code GNK: Antisera, Cf, Echovirus 1-34
GNK is the FDA product code for antisera, cf, echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GNK. The average 510(k) review took 100 days (median 100).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, Echovirus 1-34 |
| Device class | Class I |
| Regulation | 21 CFR 866.3205 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNK clearance
Top GNK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hillcrest Biologicals | 3 | 1985-11-07 |
Most recent GNK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853157 | Hillcrest Biologicals | ECHO TYPE 11 CF ANTIGEN | 1985-11-07 | 100 |
| K853156 | Hillcrest Biologicals | ECHO TYPE 16 CF ANTIGEN | 1985-11-07 | 100 |
| K853165 | Hillcrest Biologicals | ECHO TYPE 30 CF ANTIGEN | 1985-11-07 | 100 |
Recalls for GNK devices
openFDA lists no recalls for product code GNK.
Frequently asked questions
What is FDA product code GNK?
GNK is the FDA product code for antisera, cf, echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel.
What device class is GNK?
Class I, regulation 21 CFR 866.3205. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNK?
Across 3 cleared submissions the average was 100 days from receipt to decision (median 100).
Which companies have the most GNK clearances?
Hillcrest Biologicals (3).
Next steps
- Run an FDA pathway report with predicate devices for product code GNK
- Run a recall and safety report across every GNK manufacturer
- Watch product code GNK 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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