510(k) K983690

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK by Ortho-Clinical Diagnostics, Inc. — Product Code MOI

K983690 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK". The FDA issued a decision of Substantially Equivalent on February 2, 1999. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.