510(k) K042494

VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III by Ortho-Clinical Diagnostics — Product Code CZW

K042494 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III". The FDA issued a decision of Substantially Equivalent on October 19, 2004. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Ortho-Clinical Diagnostics has at least 10 other 510(k) clearances on record.