FDA 510(k) Application Details - K102342

Device Classification Name	More FDA Info for this Device
510(K) Number	K102342
Device Name	KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
Applicant	MICROPHAGE, INC. 2400 TRADE CENTRE AVENUE 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	08/18/2010
Decision Date	05/05/2011
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