510(k) K190490

VITROS XT Chemistry Products TRIG-CHOL Slides by Ortho-Clinical Diagnostics, Inc. — Product Code CHH

K190490 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS XT Chemistry Products TRIG-CHOL Slides". The FDA issued a decision of Substantially Equivalent on March 27, 2019. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.