FDA product code JMR: Immunochemical, Lysozyme (Muramidase)
JMR is the FDA product code for immunochemical, lysozyme (muramidase). It is a Class I device, regulated under 21 CFR 862.1490 and reviewed by the Clinical Chemistry panel. Devices under JMR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Immunochemical, Lysozyme (Muramidase) |
| Device class | Class I |
| Regulation | 21 CFR 862.1490 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JMR devices
openFDA lists no recalls for product code JMR.
Frequently asked questions
What is FDA product code JMR?
JMR is the FDA product code for immunochemical, lysozyme (muramidase). It is a Class I device, regulated under 21 CFR 862.1490 and reviewed by the Clinical Chemistry panel.
What device class is JMR?
Class I, regulation 21 CFR 862.1490. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JMR
- Run a recall and safety report across every JMR manufacturer
- Watch product code JMR 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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