ADVIA IMS LITHIUM ASSAY

ADVIA IMS LITHIUM ASSAY is an FDA 510(k)-cleared medical device (K050374) manufactured by Bayer Healthcare, LLC. 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 June 14, 2005. Regulation: 8.