VITROS XT Chemistry Products UREA-CREA Slides

VITROS XT Chemistry Products UREA-CREA Slides is an FDA 510(k)-cleared medical device (K190326) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 2019. Regulation: 8.