FDA 510(k) Application Details - K140647

Device Classification Name	More FDA Info for this Device
510(K) Number	K140647
Device Name	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
Applicant	LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. TORONTO, ONTARIO M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	Tina Ip Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2014
Decision Date	10/24/2014
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