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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, Cpk Or Isoenzymes
510(k) Number K780070
Device Name CPK REAGENT SET
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 Number862.1215
Classification Product Code
CGS  
Date Received01/16/1978
Decision Date 02/13/1978
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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