510(k) K063143

VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS by Ortho-Clinical Diagnostics, Inc. — Product Code LFX

K063143 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS". The FDA issued a decision of Substantially Equivalent on December 26, 2006. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.