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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
Device Name VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact MARLENE A HANNA
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent 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 (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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