510(k) K033300

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS by Ortho-Clinical Diagnostics, Inc. — Product Code DDR

K033300 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS". The FDA issued a decision of Substantially Equivalent on November 5, 2003. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.