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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
510(k) Number K191742
Device Name ARIES MRSA Assay
Luminex Corporation
12212 Technology Blvd
Austin,  TX  78727
Applicant Contact Kate Linak
Luminex Corporation
12212 Technology Blvd
Austin,  TX  78727
Correspondent Contact Kate Linak
Regulation Number866.1640
Classification Product Code
Date Received07/01/2019
Decision Date 09/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No