FDA 510(k) Application Details - K163626

Device Classification Name	More FDA Info for this Device
510(K) Number	K163626
Device Name	ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Applicant	Luminex Corporation 12212 Technology Blvd Austin, TX 78727 US Other 510(k) Applications for this Company
Contact	Kate Linak Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2016
Decision Date	05/02/2017
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