BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST

Kinetic Method, Gamma-glutamyl Transpeptidase

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol -gt Gamma-glutamyl Transferase (ggt) Test.

Pre-market Notification Details

Device IDK881311
510k NumberK881311
Device Name:BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
ClassificationKinetic Method, Gamma-glutamyl Transpeptidase
Applicant BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
Product CodeJQB  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-28
Decision Date1988-04-28

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