510(k) K163433

VITROS Chemistry Products GLU Slides by Ortho Clinical Diagnostics — Product Code CGA

K163433 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Chemistry Products GLU Slides". The FDA issued a decision of Substantially Equivalent on September 18, 2017. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.