FDA product code CJI: Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
CJI is the FDA product code for disodium phenylphosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. Devices under CJI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CJI devices
openFDA lists no recalls for product code CJI.
Frequently asked questions
What is FDA product code CJI?
CJI is the FDA product code for disodium phenylphosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel.
What device class is CJI?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CJI
- Run a recall and safety report across every CJI manufacturer
- Watch product code CJI 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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