ROCHE ACETAMINOPHEN ASSAY

ROCHE ACETAMINOPHEN ASSAY is an FDA 510(k)-cleared medical device (K110726) manufactured by Roche Diagnostics. 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 December 22, 2011. Regulation: 8.