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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nad reduction/nadh oxidation, lactate dehydrogenase
510(k) Number K915803
Device Name DMA LD KINETIC PROCEDURE
Applicant
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
arlington,  TX  76011
Applicant Contact annette t wells
Correspondent
DATA MEDICAL ASSOCIATES, INC.
845 AVENUE G EAST
arlington,  TX  76011
Correspondent Contact annette t wells
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received12/24/1991
Decision Date 03/18/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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