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Helena Laboratories Uk, Ltd.
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THE HELENA V8 IMMUNODISPLACEMENT KIT is an FDA 510(k)-cleared medical device (K111369) manufactured by Helena Laboratories Uk, Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2012. Regulation: 8.