GGT REAGENT

Colorimetric Method, Gamma-glutamyl Transpeptidase

AMRESCO, INC.

The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Ggt Reagent.

Pre-market Notification Details

Device IDK905618
510k NumberK905618
Device Name:GGT REAGENT
ClassificationColorimetric Method, Gamma-glutamyl Transpeptidase
Applicant AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon,  OH  44139
ContactLeonard Szymkowski
CorrespondentLeonard Szymkowski
AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon,  OH  44139
Product CodeJPZ  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-14
Decision Date1991-02-26

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