LACTATE DEHYDROGENASE (LD) PROCEDURE

Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

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 (ld) Procedure.

Pre-market Notification Details

Device IDK861662
510k NumberK861662
Device Name:LACTATE DEHYDROGENASE (LD) PROCEDURE
ClassificationNad Reduction/nadh Oxidation, Lactate Dehydrogenase
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 CodeCFJ  
CFR Regulation Number862.1440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-30
Decision Date1986-05-29

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