FDA 510(k) Application Details - K151906

Device Classification Name	More FDA Info for this Device
510(K) Number	K151906
Device Name	ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
Applicant	LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. AUSTIN, TX 78727 US Other 510(k) Applications for this Company
Contact	RONALD DUNN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2015
Decision Date	10/06/2015
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