FDA 510(k) Application Details - K052323

Device Classification Name	Susceptibility Test Powders, Antimycobacterial   More FDA Info for this Device
510(K) Number	K052323
Device Name	Susceptibility Test Powders, Antimycobacterial
Applicant	TREK DIAGNOSTIC SYSTEMS, INC. 210 BUSINESS PARK DR. SUN PRAIRIE, WI 53590 US Other 510(k) Applications for this Company
Contact	NADINE M SULLIVAN Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	MJA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2005
Decision Date	01/19/2006
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