FDA product code JMS: Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase
JMS is the FDA product code for acid, oxalacetic and nadh oxidation (u.v.), malic dehydrogenase. It is a Class I device, regulated under 21 CFR 862.1500 and reviewed by the Clinical Chemistry panel. Devices under JMS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase |
| Device class | Class I |
| Regulation | 21 CFR 862.1500 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JMS devices
openFDA lists no recalls for product code JMS.
Frequently asked questions
What is FDA product code JMS?
JMS is the FDA product code for acid, oxalacetic and nadh oxidation (u.v.), malic dehydrogenase. It is a Class I device, regulated under 21 CFR 862.1500 and reviewed by the Clinical Chemistry panel.
What device class is JMS?
Class I, regulation 21 CFR 862.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JMS
- Run a recall and safety report across every JMS manufacturer
- Watch product code JMS 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.
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