510(k) K121608

VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS by Ortho-Clinical Diagnostics, Inc. — Product Code MRG

K121608 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS". The FDA issued a decision of Substantially Equivalent on February 15, 2013. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.