ALANINE TRANSAMINASE (ALT) TEST KIT

Nadh Oxidation/nad Reduction, Alt/sgpt

GENETIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Alanine Transaminase (alt) Test Kit.

Pre-market Notification Details

Device IDK870879
510k NumberK870879
Device Name:ALANINE TRANSAMINASE (ALT) TEST KIT
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
ContactKrieger, Phd
CorrespondentKrieger, Phd
GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-04
Decision Date1987-03-19

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