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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 -0882
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
EASTMAN KODAK COMPANY
100 INDIGO CREEK DR.
ROCHESTER,  NY  14652 -0882
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
Recalls CDRH Recalls
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