510(k) K063720

VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS by Ortho-Clinical Diagnostics — Product Code DHA

K063720 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS". The FDA issued a decision of Substantially Equivalent on April 9, 2007. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Ortho-Clinical Diagnostics has at least 10 other 510(k) clearances on record.