FDA 510(k) Application Details - DEN130003

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130003
Device Name	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
Applicant	LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. SUITE 900 TORONTO M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	LUBNA SYED 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	01/11/2013
Decision Date	01/14/2013
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review