FDA 510(k) Application Details - K140436

Device Classification Name	More FDA Info for this Device
510(K) Number	K140436
Device Name	ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
Applicant	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355-1307 US Other 510(k) Applications for this Company
Contact	STACEY DOLAN 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	02/21/2014
Decision Date	12/23/2014
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