Emit II Plus Oxycodone Assay

Emit II Plus Oxycodone Assay is an FDA 510(k)-cleared medical device (K172910) manufactured by Siemens Healthcare 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 October 17, 2017. Regulation: 8.