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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K093611
Device Name VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
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 Number862.1160
Classification Product Code
KHS  
Date Received11/23/2009
Decision Date 04/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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