FDA product code GRK: Antisera, Fluorescent, Echovirus 1-34
GRK is the FDA product code for antisera, fluorescent, echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel. Devices under GRK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Echovirus 1-34 |
| Device class | Class I |
| Regulation | 21 CFR 866.3205 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GRK devices
openFDA lists no recalls for product code GRK.
Frequently asked questions
What is FDA product code GRK?
GRK is the FDA product code for antisera, fluorescent, echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel.
What device class is GRK?
Class I, regulation 21 CFR 866.3205. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GRK
- Run a recall and safety report across every GRK manufacturer
- Watch product code GRK 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.