510(k) K191316

VITROS XT Chemistry Products ALB-TP Slides by Ortho-Clinical Diagnostics, Inc. — Product Code CIX

K191316 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS XT Chemistry Products ALB-TP Slides". The FDA issued a decision of Substantially Equivalent on June 7, 2019. 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.