
Ortho-Clinical Diagnostics, Inc.
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VITROS Chemistry Products PHBR Slides is an FDA 510(k)-cleared medical device (K210858) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 2021. Regulation: 8.