510(k) K041720

VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II by Ortho-Clinical Diagnostics, Inc. — Product Code MRR

K041720 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II". The FDA issued a decision of Substantially Equivalent on August 25, 2004. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.