FDA product code CKF: Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
CKF is the FDA product code for phenylphosphate, 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 2 510(k) submissions under CKF, from 2 different applicants. The average 510(k) review took 178 days (median 178).
Classification
| Field | Value |
|---|---|
| Device name | 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 |
Compare with all 510(k) review times · Search every CKF clearance
Top CKF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alfa Wassermann Diagnostic Technologies, Inc. | 1 | 2008-06-26 |
| Hichem Diagnostics | 1 | 1996-09-23 |
Most recent CKF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072142 | Alfa Wassermann Diagnostic Technologies, Inc. | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST | 2008-06-26 | 329 |
| K963383 | Hichem Diagnostics | HICHEM ALP/AMP REAGENT KIT | 1996-09-23 | 27 |
Recalls for CKF devices
openFDA lists no recalls for product code CKF.
Frequently asked questions
What is FDA product code CKF?
CKF is the FDA product code for 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 CKF?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CKF?
Across 2 cleared submissions the average was 178 days from receipt to decision (median 178).
Which companies have the most CKF clearances?
Alfa Wassermann Diagnostic Technologies, Inc. (1); Hichem Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CKF
- Run a recall and safety report across every CKF manufacturer
- Watch product code CKF 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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