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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 K151917
Device Name ARIES System
Applicant
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN,  TX  78727
Applicant Contact RONALD DUNN
Correspondent
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN,  TX  78727
Correspondent Contact RONALD DUNN
Regulation Number862.2570
Classification Product Code
OOI  
Date Received07/13/2015
Decision Date 10/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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