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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 K161495
Device Name ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
Applicant
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN,  TX  78727
Applicant Contact CHRISTIE HUGHES
Correspondent
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN,  TX  78727
Correspondent Contact CHRISTIE HUGHES
Regulation Number862.2570
Classification Product Code
OOI  
Subsequent Product Code
PGI  
Date Received06/01/2016
Decision Date 06/30/2016
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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