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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Salicylate
510(k) Number K902356
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact KAREN WARREN
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact KAREN WARREN
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received05/29/1990
Decision Date 07/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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