Emit II Plus Cocaine Metabolite Assay

Emit II Plus Cocaine Metabolite Assay is an FDA 510(k)-cleared medical device (K170293) 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 24, 2017. Regulation: 8.