FDA product code JNJ: Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase
JNJ is the FDA product code for phosphoenol pyruvate, adp, nadh, pyruvate kinase. It is a Class I device, regulated under 21 CFR 862.1650 and reviewed by the Clinical Chemistry panel. Devices under JNJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase |
| Device class | Class I |
| Regulation | 21 CFR 862.1650 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JNJ devices
openFDA lists no recalls for product code JNJ.
Frequently asked questions
What is FDA product code JNJ?
JNJ is the FDA product code for phosphoenol pyruvate, adp, nadh, pyruvate kinase. It is a Class I device, regulated under 21 CFR 862.1650 and reviewed by the Clinical Chemistry panel.
What device class is JNJ?
Class I, regulation 21 CFR 862.1650. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JNJ
- Run a recall and safety report across every JNJ manufacturer
- Watch product code JNJ 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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