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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K833833
Device Name KODAK EKTACHEM 700 ANALYZER
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 Number862.2160
Classification Product Code
JJE  
Date Received11/03/1983
Decision Date 01/17/1984
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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