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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
510(k) Number K120609
Models 6801895, 6802469
Device Name VITROS CHEMISTRY PRODUCTS DHDL SLIDES
Original Applicant
ORTHO-CLINICAL DIAGNOSTICS, INC.
100 indigo creek dr.
rochester,  NY  14626 5101
Original Contact marlene a hanna
Regulation Number862.1475
Classification Product Code
LBS  
Date Received02/29/2012
Decision Date 09/07/2012
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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