FDA product code GOX: Antigen, B. Pertussis
GOX is the FDA product code for antigen, b. pertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GOX. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, B. Pertussis |
| Device class | Class I |
| Regulation | 21 CFR 866.3065 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GOX clearance
Top GOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 1 | 1979-09-24 |
Most recent GOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791454 | Volu Sol Medical Industries | AGGLUTINOTEST-PERTUSSIS | 1979-09-24 | 49 |
Recalls for GOX devices
openFDA lists no recalls for product code GOX.
Frequently asked questions
What is FDA product code GOX?
GOX is the FDA product code for antigen, b. pertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel.
What device class is GOX?
Class I, regulation 21 CFR 866.3065. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GOX?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most GOX clearances?
Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GOX
- Run a recall and safety report across every GOX manufacturer
- Watch product code GOX 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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