GOT ISOENZYME ASSAY EIKEN KIT

Nadh Oxidation/nad Reduction, Ast/sgot

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Got Isoenzyme Assay Eiken Kit.

Pre-market Notification Details

Device IDK802447
510k NumberK802447
Device Name:GOT ISOENZYME ASSAY EIKEN KIT
ClassificationNadh Oxidation/nad Reduction, Ast/sgot
Applicant SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIT  
CFR Regulation Number862.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-08
Decision Date1981-04-17

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