FDA product code GPP: Antiserum, Rocky Mountain Spotted Fever
GPP is the FDA product code for antiserum, rocky mountain spotted 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 GPP. The average 510(k) review took 99 days (median 99).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Rocky Mountain Spotted 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 GPP clearance
Top GPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Health Research, Inc. | 1 | 1985-01-04 |
Most recent GPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843794 | Health Research, Inc. | LATEX-R RICKETTSII | 1985-01-04 | 99 |
Recalls for GPP devices
openFDA lists no recalls for product code GPP.
Frequently asked questions
What is FDA product code GPP?
GPP is the FDA product code for antiserum, rocky mountain spotted fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPP?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GPP?
Across 1 cleared submissions the average was 99 days from receipt to decision (median 99).
Which companies have the most GPP clearances?
Health Research, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GPP
- Run a recall and safety report across every GPP manufacturer
- Watch product code GPP 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times