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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K161220
Device Name ARIES® Flu A/B & RSV Assay
Applicant
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD
AUSTIN,  TX  78727
Applicant Contact WENDY RICKER
Correspondent
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD
AUSTIN,  TX  78727
Correspondent Contact WENDY RICKER
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OOI   OZE  
Date Received04/29/2016
Decision Date 08/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02087761
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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