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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c. difficile toxin gene amplification assay
510(k) Number K171441
Device Name ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
Luminex Corporation
12212 Technology Blvd.
Austin,  TX  78727
Applicant Contact Wendy Ricker
Luminex Corporation
12212 Technology Blvd.
Austin,  TX  78727
Correspondent Contact Wendy Ricker
Regulation Number866.3130
Classification Product Code
Subsequent Product Code
Date Received05/16/2017
Decision Date 07/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02497417
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls