FDA product code GNJ: Antigens, Ha, Echovirus 1-34
GNJ is the FDA product code for antigens, ha, echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GNJ. The average 510(k) review took 127 days (median 127).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Ha, 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 GNJ clearance
Top GNJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 1 | 1983-05-25 |
Most recent GNJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830173 | Jedmed Instrument Co. | BERA SH 221 BRIAN STEM AUDIOMETER | 1983-05-25 | 127 |
Recalls for GNJ devices
openFDA lists no recalls for product code GNJ.
Frequently asked questions
What is FDA product code GNJ?
GNJ is the FDA product code for antigens, ha, 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 GNJ?
Class I, regulation 21 CFR 866.3205. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNJ?
Across 1 cleared submissions the average was 127 days from receipt to decision (median 127).
Which companies have the most GNJ clearances?
Jedmed Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GNJ
- Run a recall and safety report across every GNJ manufacturer
- Watch product code GNJ 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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