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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 K903829
Device Name AST REAGENT
Applicant
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Applicant Contact PRAFUL PATEL
Correspondent
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Correspondent Contact PRAFUL PATEL
Regulation Number862.1100
Classification Product Code
CIT  
Date Received08/21/1990
Decision Date 09/25/1990
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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