FDA product code CJL: Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes
CJL is the FDA product code for beta glycerophosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CJL. The average 510(k) review took 112 days (median 112).
Classification
| Field | Value |
|---|---|
| Device name | Beta Glycerophosphate, 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 |
Compare with all 510(k) review times · Search every CJL clearance
Top CJL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anco Medical Reagents & Assoc. | 1 | 1982-01-29 |
Most recent CJL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812837 | Anco Medical Reagents & Assoc. | ALKALINE PHOSPHATASE REAGENT SET | 1982-01-29 | 112 |
Recalls for CJL devices
openFDA lists no recalls for product code CJL.
Frequently asked questions
What is FDA product code CJL?
CJL is the FDA product code for beta glycerophosphate, 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 CJL?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJL?
Across 1 cleared submissions the average was 112 days from receipt to decision (median 112).
Which companies have the most CJL clearances?
Anco Medical Reagents & Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJL
- Run a recall and safety report across every CJL manufacturer
- Watch product code CJL 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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