CHOLESTEROL PROCEDURE

Enzymatic Esterase--oxidase, Cholesterol

DATA MEDICAL ASSOCIATES, INC.

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

Pre-market Notification Details

Device IDK863252
510k NumberK863252
Device Name:CHOLESTEROL PROCEDURE
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactMarjorie B Potts
CorrespondentMarjorie B Potts
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-25
Decision Date1986-09-29

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