FDA product code GPM: Antiserum, Murine Typhus Fever
GPM is the FDA product code for antiserum, murine typhus fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GPM. The average 510(k) review took 66 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Murine Typhus 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 GPM clearance
Top GPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Health Research, Inc. | 1 | 1986-04-21 |
Most recent GPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860557 | Health Research, Inc. | LATEX R. TYPHI | 1986-04-21 | 66 |
Recalls for GPM devices
openFDA lists no recalls for product code GPM.
Frequently asked questions
What is FDA product code GPM?
GPM is the FDA product code for antiserum, murine typhus fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPM?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GPM?
Across 1 cleared submissions the average was 66 days from receipt to decision (median 66).
Which companies have the most GPM clearances?
Health Research, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GPM
- Run a recall and safety report across every GPM manufacturer
- Watch product code GPM 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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