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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K910143
Device Name KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
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 Number862.1410
Classification Product Code
JIY  
Date Received01/14/1991
Decision Date 02/04/1991
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
Recalls CDRH Recalls
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