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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K881639
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact NORMAN H GEIL
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact NORMAN H GEIL
Regulation Number862.1635
Classification Product Code
CEK  
Date Received04/14/1988
Decision Date 07/08/1988
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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