510(k) K043384

VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III by Ortho-Clinical Diagnostics, Inc. — Product Code LDO

K043384 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III". The FDA issued a decision of Substantially Equivalent on February 7, 2005. The device falls under product code LDO (Enzymatic Radiochemical Assay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.