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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 K842521
Device Name AST/GOT REAGENT SET UV RATE
Applicant
Sterling Biochemical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sterling Biochemical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1100
Classification Product Code
CIT  
Date Received06/27/1984
Decision Date 08/12/1984
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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