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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 K852783
Device Name SGOT/ALT REAGENT
Applicant
Advanced Biomedical Methods, Inc.
P.O. Box 48026
Niles,  IL  60648
Applicant Contact JACK M GOLDBERG
Correspondent
Advanced Biomedical Methods, Inc.
P.O. Box 48026
Niles,  IL  60648
Correspondent Contact JACK M GOLDBERG
Regulation Number862.1100
Classification Product Code
CIT  
Date Received07/01/1985
Decision Date 07/22/1985
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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