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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 K922072
Device Name KODAK EKTACHEM 250 ANALYER
Original Applicant
EASTMAN KODAK COMPANY
343 state st.
rochester,  NY  14650
Original Contact yvonne adair
Regulation Number862.2160
Classification Product Code
JJE  
Date Received05/04/1992
Decision Date 07/10/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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