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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K904768
Device Name KODATROL I AND II CONTROL AND DILUENT SET
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 Number862.1660
Classification Product Code
JJY  
Date Received10/22/1990
Decision Date 11/09/1990
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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