FDA product code JCJ: Alkaline Phosphatase
JCJ is the FDA product code for alkaline phosphatase. It is a Class I device, regulated under 21 CFR 864.7660 and reviewed by the Hematology panel. Devices under JCJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Alkaline Phosphatase |
| Device class | Class I |
| Regulation | 21 CFR 864.7660 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for JCJ devices
openFDA lists no recalls for product code JCJ.
Frequently asked questions
What is FDA product code JCJ?
JCJ is the FDA product code for alkaline phosphatase. It is a Class I device, regulated under 21 CFR 864.7660 and reviewed by the Hematology panel.
What device class is JCJ?
Class I, regulation 21 CFR 864.7660. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JCJ
- Run a recall and safety report across every JCJ manufacturer
- Watch product code JCJ 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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