FDA 510(k) Application Details - K121461

Device Classification Name	System, Blood Culturing   More FDA Info for this Device
510(K) Number	K121461
Device Name	System, Blood Culturing
Applicant	BIOMERIEUX, INC. 100 RODOLPHE ST DURHAM, NC 27712 US Other 510(k) Applications for this Company
Contact	JOCELYN JENNINGS Other 510(k) Applications for this Contact
Regulation Number	866.2560   More FDA Info for this Regulation Number
Classification Product Code	MDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2012
Decision Date	01/22/2013
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