ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM

ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM is an FDA 510(k)-cleared medical device (K102283) manufactured by Zeus Scientific, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2011. Regulation: 8.