FDA 510(k) Application Details - K093758

Device Classification Name	More FDA Info for this Device
510(K) Number	K093758
Device Name	BGM GALECTIN -3
Applicant	BG MEDICINE, INC. 610N LINCOLN ST. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	Carol Adiletto Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2009
Decision Date	11/17/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review