FDA Product Code
FDA Product Code CKF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1050
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072142 | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 | Traditional | PDF ↗ |
| K963383 | HICHEM ALP/AMP REAGENT KIT | Hichem Diagnostics | 1996-09-23 | Traditional | PDF ↗ |
Product code CKF · Class II · Clinical Chemistry. Data: openFDA.