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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name differential rate kinetic method, cpk or isoenzymes
510(k) Number K820722
Device Name KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
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 Number862.1215
Classification Product Code
JHS  
Date Received03/16/1982
Decision Date 04/01/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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