FDA 510(k) Application Details - K080008

Device Classification Name	Multiplex Flow Immunoassay, T.Gondii, Rubella And Cmv.   More FDA Info for this Device
510(K) Number	K080008
Device Name	Multiplex Flow Immunoassay, T.Gondii, Rubella And Cmv.
Applicant	BIO-RAD LABORATORIES, INC. 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA SINCLAIR Other 510(k) Applications for this Contact
Regulation Number	866.3510   More FDA Info for this Regulation Number
Classification Product Code	OMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2008
Decision Date	02/23/2009
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