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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, Alt/Sgpt
510(k) Number K844251
Device Name ALT/GPT REAGENT SET
Applicant
Sterling Biochemical, Inc.
20200 W. Outer Dr.
Dearborn,  MI  48124
Applicant Contact DAVID L CALLENDER
Correspondent
Sterling Biochemical, Inc.
20200 W. Outer Dr.
Dearborn,  MI  48124
Correspondent Contact DAVID L CALLENDER
Regulation Number862.1030
Classification Product Code
CKA  
Date Received11/02/1984
Decision Date 01/08/1985
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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