ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM

ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM is an FDA 510(k)-cleared medical device (K093837) manufactured by Zeus Scientific, Inc. (Zeus). This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 30, 2010. Regulation: 8.