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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bordetella pertussis dna assay system
510(k) Number K163626
Device Name ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Applicant
Luminex Corporation
12212 Technology Blvd
Austin,  TX  78727
Applicant Contact Kate Linak
Correspondent
Luminex Corporation
12212 Technology Blvd
Austin,  TX  78727
Correspondent Contact Kate Linak
Regulation Number866.3980
Classification Product Code
OZZ  
Date Received12/22/2016
Decision Date 05/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02862262
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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