FDA product code JMJ: Microbiological, Histidine
JMJ is the FDA product code for microbiological, histidine. It is a Class I device, regulated under 21 CFR 862.1375 and reviewed by the Clinical Chemistry panel. Devices under JMJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Microbiological, Histidine |
| Device class | Class I |
| Regulation | 21 CFR 862.1375 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JMJ devices
openFDA lists no recalls for product code JMJ.
Frequently asked questions
What is FDA product code JMJ?
JMJ is the FDA product code for microbiological, histidine. It is a Class I device, regulated under 21 CFR 862.1375 and reviewed by the Clinical Chemistry panel.
What device class is JMJ?
Class I, regulation 21 CFR 862.1375. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JMJ
- Run a recall and safety report across every JMJ manufacturer
- Watch product code JMJ 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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