GENIE CUP INTEGRATED SCREENING DEVICE

GENIE CUP INTEGRATED SCREENING DEVICE is an FDA 510(k)-cleared medical device (K980836) manufactured by Applied Technology Ventures, 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 28, 1998. Regulation: 8.