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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 K841503
Device Name KODAK EKTACHEM DT 60 ANALYZER
Applicant
EASTMAN KODAK COMPANY
NY 
Correspondent
EASTMAN KODAK COMPANY
NY 
Regulation Number862.2160
Classification Product Code
JJE  
Date Received04/10/1984
Decision Date 05/22/1984
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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