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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name alkaline picrate, colorimetry, creatinine
510(k) Number K934071
Device Name KODAK EKTACHEM DT SLIDES (URCR)
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Applicant Contact BRADFORD M SPRING
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Correspondent Contact BRADFORD M SPRING
Regulation Number862.1225
Classification Product Code
CGX  
Date Received08/20/1993
Decision Date 03/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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