FDA 510(k) Applications for Medical Device Product Code "OSX"

FDA 510(k) Number Applicant Device Name Decision Date
K093758 BG MEDICINE, INC. BGM GALECTIN -3 11/17/2010
K140436 FUJIREBIO DIAGNOSTICS, INC. ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS 12/23/2014


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