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Focus Technologies, Inc.
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HERPESELECT 2 ELISA IGG, MODEL ELO920G is an FDA 510(k)-cleared medical device (K021486) manufactured by Focus Technologies, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 2002. Regulation: 8.