CREATINE PHOSPHOKINASE(CK) PROCEDURE

Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Creatine Phosphokinase(ck) Procedure.

Pre-market Notification Details

Device IDK863587
510k NumberK863587
Device Name:CREATINE PHOSPHOKINASE(CK) PROCEDURE
ClassificationNad Reduction/nadh Oxidation, Cpk Or Isoenzymes
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 CodeCGS  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-15
Decision Date1986-10-03

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