
Fujirebio Diagnostics,Inc.
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ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS is an FDA 510(k)-cleared medical device (K140436) manufactured by Fujirebio Diagnostics,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 December 22, 2014. Regulation: 8.