510(k) K990943

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK by Ortho-Clinical Diagnostics, Inc. — Product Code DHX

K990943 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK". The FDA issued a decision of Substantially Equivalent on June 1, 1999. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.