510(k) K993068

VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS by Ortho-Clinical Diagnostics — Product Code JHX

K993068 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS". The FDA issued a decision of Substantially Equivalent on October 4, 1999. The device falls under product code JHX (Fluorometric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Ortho-Clinical Diagnostics has at least 10 other 510(k) clearances on record.