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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 K791080
Device Name PLUS CHEM S.C.E. REAGENT
Applicant
Smithkline Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Smithkline Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1100
Classification Product Code
CIT  
Date Received06/12/1979
Decision Date 07/24/1979
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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