FDA 510(k) Application Details - K120563

Device Classification Name	More FDA Info for this Device
510(K) Number	K120563
Device Name	KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
Applicant	MICROPHAGE, INC. 2400 TRADE CENTRE AVE LONGMONT, CO 80503 US Other 510(k) Applications for this Company
Contact	DREW SMITH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2012
Decision Date	03/30/2012
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