510(k) K042520

VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III by Ortho-Clinical Diagnostics, Inc. — Product Code KLS

K042520 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III". The FDA issued a decision of Substantially Equivalent on November 30, 2004. The device falls under product code KLS (Enzyme Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.