FDA product code GSW: Antiserum, Flavobacterium Meningosepticum, All Groups
GSW is the FDA product code for antiserum, flavobacterium meningosepticum, all groups. It is a Class I device, regulated under 21 CFR 866.3270 and reviewed by the Microbiology panel. Devices under GSW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Flavobacterium Meningosepticum, All Groups |
| Device class | Class I |
| Regulation | 21 CFR 866.3270 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GSW devices
openFDA lists no recalls for product code GSW.
Frequently asked questions
What is FDA product code GSW?
GSW is the FDA product code for antiserum, flavobacterium meningosepticum, all groups. It is a Class I device, regulated under 21 CFR 866.3270 and reviewed by the Microbiology panel.
What device class is GSW?
Class I, regulation 21 CFR 866.3270. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GSW
- Run a recall and safety report across every GSW manufacturer
- Watch product code GSW 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.