510(k) K072443

VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY by Ortho-Clinical Diagnostics, Inc. — Product Code CJY

K072443 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY". The FDA issued a decision of Substantially Equivalent on September 24, 2007. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.