FDA 510(k) Application Details - K071146

Device Classification Name	Antigen, Inflammatory Response Marker, Sepsis   More FDA Info for this Device
510(K) Number	K071146
Device Name	Antigen, Inflammatory Response Marker, Sepsis
Applicant	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US Other 510(k) Applications for this Company
Contact	NIKITA S MAPP Other 510(k) Applications for this Contact
Regulation Number	866.3210   More FDA Info for this Regulation Number
Classification Product Code	NTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2007
Decision Date	10/11/2007
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