FDA product code JMH: Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase
JMH is the FDA product code for fluorescence, visual observation (qual., u.v.), glutathione reductase. It is a Class II device, regulated under 21 CFR 864.7375 and reviewed by the Hematology panel. Devices under JMH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase |
| Device class | Class II |
| Regulation | 21 CFR 864.7375 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for JMH devices
openFDA lists no recalls for product code JMH.
Frequently asked questions
What is FDA product code JMH?
JMH is the FDA product code for fluorescence, visual observation (qual., u.v.), glutathione reductase. It is a Class II device, regulated under 21 CFR 864.7375 and reviewed by the Hematology panel.
What device class is JMH?
Class II, regulation 21 CFR 864.7375. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JMH
- Run a recall and safety report across every JMH manufacturer
- Watch product code JMH 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.