CREATINE KINASE (CK) ISOENZYME MB

Chromatographic Separation, Cpk 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 Kinase (ck) Isoenzyme Mb.

Pre-market Notification Details

Device IDK881168
510k NumberK881168
Device Name:CREATINE KINASE (CK) ISOENZYME MB
ClassificationChromatographic Separation, Cpk 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 CodeJHT  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-18
Decision Date1988-11-10

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