ARIES® Flu A/B & RSV Assay

Respiratory Virus Panel Nucleic Acid Assay System

LUMINEX CORPORATION

The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries® Flu A/b & Rsv Assay.

Pre-market Notification Details

• Device ID: K161220
• 510k Number: K161220
• Device Name: ARIES® Flu A/B & RSV Assay
• Classification: Respiratory Virus Panel Nucleic Acid Assay System
• Applicant: LUMINEX CORPORATION 12212 TECHNOLOGY BLVD Austin, TX 78727
• Contact: Wendy Ricker
• Correspondent: Wendy Ricker; LUMINEX CORPORATION 12212 TECHNOLOGY BLVD Austin, TX 78727
• Product Code: OCC
• Subsequent Product Code: OOI
• Subsequent Product Code: OZE
• CFR Regulation Number: 866.3980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-29
• Decision Date: 2016-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840487100158	K161220	000
00840487100080	K161220	000