510(k) K023875

VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 by Ortho-Clinical Diagnostics, Inc. — Product Code CIX

K023875 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4". The FDA issued a decision of Substantially Equivalent on December 10, 2002. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.