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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, Potassium
510(k) Number K083680
Device Name VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Mc 00882
Rochester,  NY  14626 -5101
Applicant Contact MARLENE A HANNA
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Mc 00882
Rochester,  NY  14626 -5101
Correspondent Contact MARLENE A HANNA
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Code
JIX  
Date Received12/12/2008
Decision Date 02/27/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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