FDA product code GNL: Antigens, Cf (Including Cf Control), Echovirus 1-34
GNL is the FDA product code for antigens, cf (including cf control), echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GNL. The average 510(k) review took 82 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf (Including Cf Control), 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 GNL clearance
Top GNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hillcrest Biologicals | 2 | 1985-03-05 |
Most recent GNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844695 | Hillcrest Biologicals | ECHO TYPE 4 CF ANTIGEN | 1985-03-05 | 92 |
| K844967 | Hillcrest Biologicals | ECHO TYPE 9 CF ANTIGEN | 1985-03-05 | 71 |
Recalls for GNL devices
openFDA lists no recalls for product code GNL.
Frequently asked questions
What is FDA product code GNL?
GNL is the FDA product code for antigens, cf (including cf control), 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 GNL?
Class I, regulation 21 CFR 866.3205. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNL?
Across 2 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most GNL clearances?
Hillcrest Biologicals (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GNL
- Run a recall and safety report across every GNL manufacturer
- Watch product code GNL 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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