FDA 510(k) Application Details - K183023

Device Classification Name	More FDA Info for this Device
510(K) Number	K183023
Device Name	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Applicant	Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto 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	11/01/2018
Decision Date	11/30/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review