FDA product code CJK: Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
CJK is the FDA product code for phenolphthalein phosphate, 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 CJK. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Phenolphthalein Phosphate, 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 CJK clearance
Top CJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1988-03-01 |
Most recent CJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880344 | Bd Becton Dickinson Vacutainer Systems Preanalytic | IQ ALKALINE PHOSPHATASE | 1988-03-01 | 35 |
Recalls for CJK devices
openFDA lists no recalls for product code CJK.
Frequently asked questions
What is FDA product code CJK?
CJK is the FDA product code for phenolphthalein phosphate, 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 CJK?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJK?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most CJK clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJK
- Run a recall and safety report across every CJK manufacturer
- Watch product code CJK 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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