FDA product code JWR: Atp Release (Luminescence)
JWR is the FDA product code for atp release (luminescence). It is a Class I device, regulated under 21 CFR 864.7040 and reviewed by the Hematology panel. Devices under JWR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Atp Release (Luminescence) |
| Device class | Class I |
| Regulation | 21 CFR 864.7040 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for JWR devices
openFDA lists no recalls for product code JWR.
Frequently asked questions
What is FDA product code JWR?
JWR is the FDA product code for atp release (luminescence). It is a Class I device, regulated under 21 CFR 864.7040 and reviewed by the Hematology panel.
What device class is JWR?
Class I, regulation 21 CFR 864.7040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JWR
- Run a recall and safety report across every JWR manufacturer
- Watch product code JWR 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.