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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 K934413
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
Applicant
Eastman Kodak Company
100 Indigo Creek Dr.
Rochester,  NY  14652
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
Eastman Kodak Company
100 Indigo Creek Dr.
Rochester,  NY  14652
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number862.1100
Classification Product Code
CIT  
Date Received09/10/1993
Decision Date 04/25/1994
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
Recalls CDRH Recalls
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