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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name real time nucleic acid amplification system
510(k) Number K160517
Device Name ARIES System
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 Number862.2570
Classification Product Code
OOI  
Date Received02/24/2016
Decision Date 04/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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