510(k) K190520

VITROS XT Chemistry Products GLU-Ca Slides by Ortho-Clinical Diagnostics, Inc. — Product Code CGA

K190520 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS XT Chemistry Products GLU-Ca Slides". The FDA issued a decision of Substantially Equivalent on April 3, 2019. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.