FDA 510(k) Application Details - K172402

Device Classification Name	More FDA Info for this Device
510(K) Number	K172402
Device Name	ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Applicant	Luminex Corporation 12212 Technology Blvd. Austin, TX 78727 US Other 510(k) Applications for this Company
Contact	Jennifer Grimes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2017
Decision Date	10/30/2017
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