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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 K781724
Device Name NAD REDUCTION METHOD, LACTATE PYRIVATE
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICAL ANALYSIS SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received10/11/1978
Decision Date 11/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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