FDA product code GPJ: Antiserum, Fluorescent, Q Fever
GPJ is the FDA product code for antiserum, fluorescent, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GPJ. The average 510(k) review took 286 days (median 286).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, Q Fever |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GPJ clearance
Top GPJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hillcrest Biologicals | 2 | 1992-10-21 |
Most recent GPJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913906 | Hillcrest Biologicals | Q FEVER IGG IFA TEST | 1992-10-21 | 418 |
| K922374 | Hillcrest Biologicals | Q FEVER IGM IFA TEST | 1992-10-21 | 154 |
Recalls for GPJ devices
openFDA lists no recalls for product code GPJ.
Frequently asked questions
What is FDA product code GPJ?
GPJ is the FDA product code for antiserum, fluorescent, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPJ?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GPJ?
Across 2 cleared submissions the average was 286 days from receipt to decision (median 286).
Which companies have the most GPJ clearances?
Hillcrest Biologicals (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GPJ
- Run a recall and safety report across every GPJ manufacturer
- Watch product code GPJ 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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