FDA product code CJC: Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
CJC is the FDA product code for fructose-1, 6-diphosphate and nadh (u.v.), aldolase. It is a Class I device, regulated under 21 CFR 862.1040 and reviewed by the Clinical Chemistry panel. Devices under CJC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase |
| Device class | Class I |
| Regulation | 21 CFR 862.1040 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CJC devices
openFDA lists no recalls for product code CJC.
Frequently asked questions
What is FDA product code CJC?
CJC is the FDA product code for fructose-1, 6-diphosphate and nadh (u.v.), aldolase. It is a Class I device, regulated under 21 CFR 862.1040 and reviewed by the Clinical Chemistry panel.
What device class is CJC?
Class I, regulation 21 CFR 862.1040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CJC
- Run a recall and safety report across every CJC manufacturer
- Watch product code CJC 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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