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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 K120765
Device Name VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact GAOZHEN HANG
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact GAOZHEN HANG
Regulation Number862.1160
Classification Product Code
KHS  
Date Received03/13/2012
Decision Date 10/24/2012
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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