FDA 510(k) Application Details - K093678

Device Classification Name	Antigen, Galactomannan, Aspergillus Spp.   More FDA Info for this Device
510(K) Number	K093678
Device Name	Antigen, Galactomannan, Aspergillus Spp.
Applicant	BIO-RAD 6565 185TH AVENUE NE REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER BENTSEN Other 510(k) Applications for this Contact
Regulation Number	866.3040   More FDA Info for this Regulation Number
Classification Product Code	NOM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2009
Decision Date	01/13/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review