GAMMA-GT REAGENT SYSTEM

Kinetic Method, Gamma-glutamyl Transpeptidase

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Gamma-gt Reagent System.

Pre-market Notification Details

Device IDK810434
510k NumberK810434
Device Name:GAMMA-GT REAGENT SYSTEM
ClassificationKinetic Method, Gamma-glutamyl Transpeptidase
Applicant AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJQB  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-19
Decision Date1981-02-26

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