GLUCOSE HK PROCEDURE

Glucose Oxidase, Glucose

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Glucose Hk Procedure.

Pre-market Notification Details

Device IDK861653
510k NumberK861653
Device Name:GLUCOSE HK PROCEDURE
ClassificationGlucose Oxidase, Glucose
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 CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-30
Decision Date1986-05-23

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