Atlas FDA

CKF

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1050
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST (K072142)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-26
HICHEM ALP/AMP REAGENT KIT (K963383)Hichem Diagnostics1996-09-23

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