FDA 510(k) Application Details - K070310

Device Classification Name	Antigen, Inflammatory Response Marker, Sepsis   More FDA Info for this Device
510(K) Number	K070310
Device Name	Antigen, Inflammatory Response Marker, Sepsis
Applicant	BRAHMS AKTIENGESELLSCHAFT 2568A RIVA ROAD SUITE 207 ANNAPOLIS, MD 21401 US Other 510(k) Applications for this Company
Contact	JONAS LEICHTNER 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	02/01/2007
Decision Date	03/31/2008
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