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Monobind, Inc.
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ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 is an FDA 510(k)-cleared medical device (K063437) manufactured by Monobind, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2008. Regulation: 8.