FDA 510(k) Application Details - K160517

Device Classification Name	Real Time Nucleic Acid Amplification System   More FDA Info for this Device
510(K) Number	K160517
Device Name	Real Time Nucleic Acid Amplification System
Applicant	LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. AUSTIN, TX 78727 US Other 510(k) Applications for this Company
Contact	Wendy Ricker Other 510(k) Applications for this Contact
Regulation Number	862.2570   More FDA Info for this Regulation Number
Classification Product Code	OOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2016
Decision Date	04/12/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review