FDA product code JMN: Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline
JMN is the FDA product code for extraction plus chromatography with color by ninhydrin, hydroxyproline. It is a Class I device, regulated under 21 CFR 862.1400 and reviewed by the Clinical Chemistry panel. Devices under JMN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline |
| Device class | Class I |
| Regulation | 21 CFR 862.1400 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JMN devices
openFDA lists no recalls for product code JMN.
Frequently asked questions
What is FDA product code JMN?
JMN is the FDA product code for extraction plus chromatography with color by ninhydrin, hydroxyproline. It is a Class I device, regulated under 21 CFR 862.1400 and reviewed by the Clinical Chemistry panel.
What device class is JMN?
Class I, regulation 21 CFR 862.1400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JMN
- Run a recall and safety report across every JMN manufacturer
- Watch product code JMN 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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