FDA 510(k) Application Details - K091616

Device Classification Name	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus   More FDA Info for this Device
510(K) Number	K091616
Device Name	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Applicant	Bio-Rad Laboratories 6565 185TH AVE, NE REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	DAVID BHEND Other 510(k) Applications for this Contact
Regulation Number	866.3510   More FDA Info for this Regulation Number
Classification Product Code	OPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2009
Decision Date	03/29/2010
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