FLUORESCENT TREPONEMEL ANTIBODY-ABSORB

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB is an FDA 510(k)-cleared medical device (K843613) manufactured by Immuno-Products Industries. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 1984. Regulation: 8.