510(k) K120609

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

K120609 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS DHDL SLIDES". The FDA issued a decision of Substantially Equivalent on September 7, 2012. The device falls under product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.