FDA 510(k) Application Details - K111072

Device Classification Name	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus   More FDA Info for this Device
510(K) Number	K111072
Device Name	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Applicant	Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 US Other 510(k) Applications for this Company
Contact	Juang Wang 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	04/18/2011
Decision Date	08/23/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review