
Helena Laboratories
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SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 is an FDA 510(k)-cleared medical device (K024162) 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 18, 2003. Regulation: 8.