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510(k) K120609

VITROS CHEMISTRY PRODUCTS DHDL SLIDES by Ortho-Clinical Diagnostics, Inc. — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2012
Date Received
February 29, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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