AST ASPARTATE AMINOTRANSFERASE REAGENT

Nadh Oxidation/nad Reduction, Ast/sgot

ALPKEM CORP.

The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Ast Aspartate Aminotransferase Reagent.

Pre-market Notification Details

Device IDK851994
510k NumberK851994
Device Name:AST ASPARTATE AMINOTRANSFERASE REAGENT
ClassificationNadh Oxidation/nad Reduction, Ast/sgot
Applicant ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
ContactYosip F Warda
CorrespondentYosip F Warda
ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
Product CodeCIT  
CFR Regulation Number862.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-07
Decision Date1985-06-03

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