FDA product code JMY: Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase
JMY is the FDA product code for citrulline, arsenate, nessler (colorimetry), ornithine carbamyl transferase. It is a Class I device, regulated under 21 CFR 862.1535 and reviewed by the Clinical Chemistry panel. Devices under JMY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase |
| Device class | Class I |
| Regulation | 21 CFR 862.1535 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JMY devices
openFDA lists no recalls for product code JMY.
Frequently asked questions
What is FDA product code JMY?
JMY is the FDA product code for citrulline, arsenate, nessler (colorimetry), ornithine carbamyl transferase. It is a Class I device, regulated under 21 CFR 862.1535 and reviewed by the Clinical Chemistry panel.
What device class is JMY?
Class I, regulation 21 CFR 862.1535. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JMY
- Run a recall and safety report across every JMY manufacturer
- Watch product code JMY 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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