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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase-esterase, enzymatic, photometric, lipase
510(k) Number K845027
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact PHILIP J HARTER
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact PHILIP J HARTER
Regulation Number862.1465
Classification Product Code
CHI  
Date Received12/27/1984
Decision Date 01/18/1985
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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