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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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