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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 K946090
Device Name KODAK EKTACCHEM 950IRC ANALYZER
Applicant
CLINICAL DIAGNOSTIC SYSTEMS, INC.
601 LEE RD.
ROCHESTER,  NY  14652 -3104
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
CLINICAL DIAGNOSTIC SYSTEMS, INC.
601 LEE RD.
ROCHESTER,  NY  14652 -3104
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number862.2160
Classification Product Code
JJE  
Date Received12/13/1994
Decision Date 01/17/1995
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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