CKF · Class II · 21 CFR 862.1050

FDA Product Code CKF: Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Leading manufacturers include Alfa Wassermann Diagnostic Technologies, Inc. and Hichem Diagnostics.

2
Total
2
Cleared
178d
Avg days
1996
Since

FDA 510(k) Cleared Phenylphosphate, Alkaline Phosphatase Or Isoenzymes Devices (Product Code CKF)

2 devices
1–2 of 2
Cleared Jun 26, 2008
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
K072142
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 329d
Cleared Sep 23, 1996
HICHEM ALP/AMP REAGENT KIT
K963383
Hichem Diagnostics
Chemistry · 27d

About Product Code CKF - Regulatory Context