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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
Model 826 2396
Device Name VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
Original Applicant
ORTHO-CLINICAL DIAGNOSTICS, INC.
100 indigo creek dr.
rochester,  NY  14626 5101
Original Contact gaozhen hang
Regulation Number862.1160
Classification Product Code
KHS  
Date Received03/13/2012
Decision Date 10/24/2012
Decision substantially equivalent (SE)
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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