TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER is an FDA 510(k)-cleared medical device (K891683) manufactured by Helena Laboratories. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 1989. Regulation: 8.