
Helena Laboratories
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TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 is an FDA 510(k)-cleared medical device (K900422) 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 February 26, 1990. Regulation: 8.