FDA 510(k) Application Details - K120911

Device Classification Name	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification   More FDA Info for this Device
510(K) Number	K120911
Device Name	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Applicant	CEPHEID 904 CARIBBEAN DRIVE SUNNYVALE, CA 94089-1189 US Other 510(k) Applications for this Company
Contact	KERRY J FLOM Other 510(k) Applications for this Contact
Regulation Number	866.3332   More FDA Info for this Regulation Number
Classification Product Code	OQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2012
Decision Date	05/18/2012
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