FDA product code GPK: Antiserum, Rickettsial Pox
GPK is the FDA product code for antiserum, rickettsial pox. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. Devices under GPK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Rickettsial Pox |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GPK devices
openFDA lists no recalls for product code GPK.
Frequently asked questions
What is FDA product code GPK?
GPK is the FDA product code for antiserum, rickettsial pox. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPK?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GPK
- Run a recall and safety report across every GPK manufacturer
- Watch product code GPK 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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