GAMMA-GLUTAMYL TRANSFERASE DETERMINATION

Kinetic Method, Gamma-glutamyl Transpeptidase

BIOCHEMICAL TRADE, INC.

The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Gamma-glutamyl Transferase Determination.

Pre-market Notification Details

Device IDK905649
510k NumberK905649
Device Name:GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
ClassificationKinetic Method, Gamma-glutamyl Transpeptidase
Applicant BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami,  FL  33166
ContactAlejo V Roy
CorrespondentAlejo V Roy
BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami,  FL  33166
Product CodeJQB  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-18
Decision Date1991-01-30

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