GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED

Kinetic 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 Ggt Procedure Or Gamma Glutamyl Transferase Proced.

Pre-market Notification Details

Device IDK844720
510k NumberK844720
Device Name:GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
ClassificationKinetic Method, Gamma-glutamyl Transpeptidase
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactJerry A Graham
CorrespondentJerry A Graham
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeJQB  
CFR Regulation Number862.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-04
Decision Date1984-12-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.