FLOW-PAC GGT REAGENT SET

Kinetic Method, Gamma-glutamyl Transpeptidase

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow-pac Ggt Reagent Set.

Pre-market Notification Details

Device IDK833029
510k NumberK833029
Device Name:FLOW-PAC GGT REAGENT SET
ClassificationKinetic Method, Gamma-glutamyl Transpeptidase
Applicant AMERICAN RESEARCH PRODUCTS CO. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJQB  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-07
Decision Date1983-12-29

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