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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Ast/Sgot
510(k) Number K792208
Device Name DURAZYME GOT/AST
Applicant
American Monitor Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Monitor Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1100
Classification Product Code
CIT  
Date Received11/02/1979
Decision Date 11/27/1979
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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