510(k) K042479

VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE by Ortho-Clinical Diagnostics, Inc. — Product Code LCD

K042479 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE". The FDA issued a decision of Substantially Equivalent on January 6, 2005. The device falls under product code LCD (Enzyme Immunoassay, Gentamicin), a Class II device regulated under 21 CFR 862.3450. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.