TRACE GAMMA GT-SS REAGENT

Kinetic Method, Gamma-glutamyl Transpeptidase

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Trace Gamma Gt-ss Reagent.

Pre-market Notification Details

Device IDK914731
510k NumberK914731
Device Name:TRACE GAMMA GT-SS REAGENT
ClassificationKinetic Method, Gamma-glutamyl Transpeptidase
Applicant TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
ContactPeter Murphy
CorrespondentPeter Murphy
TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
Product CodeJQB  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-21
Decision Date1991-11-19

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