510(k) K190807

VITROS XT Chemistry Products TBIL-ALKP Slides by Ortho-Clinical Diagnostics, Inc. — Product Code CIG

K190807 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS XT Chemistry Products TBIL-ALKP Slides". The FDA issued a decision of Substantially Equivalent on April 26, 2019. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.