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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
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact YVONNE ADAIR
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact YVONNE ADAIR
Regulation Number862.2160
Classification Product Code
JJE  
Date Received05/04/1992
Decision Date 07/10/1992
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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