DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE

Colorimetric Method, Gamma-glutamyl Transpeptidase

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Gamma Glutamyltransferase (ggt) Procedure.

Pre-market Notification Details

Device IDK961919
510k NumberK961919
Device Name:DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
ClassificationColorimetric Method, Gamma-glutamyl Transpeptidase
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactC.h. Morris
CorrespondentC.h. Morris
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeJPZ  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-17
Decision Date1996-07-01
Summary:summary

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