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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
Recalls CDRH Recalls
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