FDA product code CJX: Acid Phosphatase, Disodium Phenylphosphate
CJX is the FDA product code for acid phosphatase, disodium phenylphosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel. Devices under CJX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid Phosphatase, Disodium Phenylphosphate |
| Device class | Class II |
| Regulation | 21 CFR 862.1020 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CJX devices
openFDA lists no recalls for product code CJX.
Frequently asked questions
What is FDA product code CJX?
CJX is the FDA product code for acid phosphatase, disodium phenylphosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel.
What device class is CJX?
Class II, regulation 21 CFR 862.1020. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CJX
- Run a recall and safety report across every CJX manufacturer
- Watch product code CJX 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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