510(k) K190326

VITROS XT Chemistry Products UREA-CREA Slides by Ortho-Clinical Diagnostics, Inc. — Product Code CDN

K190326 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS XT Chemistry Products UREA-CREA Slides". The FDA issued a decision of Substantially Equivalent on March 14, 2019. The device falls under product code CDN (Urease, Photometric, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.