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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K820263
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
Applicant
EASTMAN KODAK COMPANY
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EASTMAN KODAK COMPANY
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1175
Classification Product Code
CHH  
Date Received02/02/1982
Decision Date 02/18/1982
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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