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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
510(k) Number K172402
Device Name ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Applicant
Luminex Corporation
12212 Technology Blvd.
Austin,  TX  78727
Applicant Contact Jennifer Grimes
Correspondent
Luminex Corporation
12212 Technology Blvd.
Austin,  TX  78727
Correspondent Contact Jennifer Grimes
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received08/09/2017
Decision Date 10/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03037957
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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