FDA product code JMI: Chromatographic, Histidine
JMI is the FDA product code for chromatographic, histidine. It is a Class I device, regulated under 21 CFR 862.1375 and reviewed by the Clinical Chemistry panel. Devices under JMI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic, 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 JMI devices
openFDA lists no recalls for product code JMI.
Frequently asked questions
What is FDA product code JMI?
JMI is the FDA product code for chromatographic, histidine. It is a Class I device, regulated under 21 CFR 862.1375 and reviewed by the Clinical Chemistry panel.
What device class is JMI?
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 JMI
- Run a recall and safety report across every JMI manufacturer
- Watch product code JMI 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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