LACTATE DEHYDROGENASE ISOENZYME 1

Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Lactate Dehydrogenase Isoenzyme 1.

Pre-market Notification Details

Device IDK872891
510k NumberK872891
Device Name:LACTATE DEHYDROGENASE ISOENZYME 1
ClassificationChromatographic Separation, Lactate Dehydrogenase 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 CodeCEX  
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-23
Decision Date1987-09-16

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