FDA product code JMC: Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase
JMC is the FDA product code for nadp reduction (u.v.), glucose-6-phosphate dehydrogenase. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel. Devices under JMC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase |
| Device class | Class II |
| Regulation | 21 CFR 864.7360 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JMC devices
openFDA lists no recalls for product code JMC.
Frequently asked questions
What is FDA product code JMC?
JMC is the FDA product code for nadp reduction (u.v.), glucose-6-phosphate dehydrogenase. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel.
What device class is JMC?
Class II, regulation 21 CFR 864.7360. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JMC
- Run a recall and safety report across every JMC manufacturer
- Watch product code JMC 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.