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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, ion specific, sodium
510(k) Number K091861
Model 153 2290 & 195 7927
Device Name VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
Original Applicant
ORTHO-CLINICAL DIAGNOSTICS, INC.
100 indigo creek dr.
rochester,  NY  14626 5101
Original Contact marlene a hanna
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Code
JIX  
Date Received06/19/2009
Decision Date 09/03/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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