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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
Original Applicant
EASTMAN KODAK COMPANY
100 indigo creek dr.
rochester,  NY  14652 0882
Original Contact yvonne e middlefell
Regulation Number862.1100
Classification Product Code
CIT  
Date Received09/10/1993
Decision Date 04/25/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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