• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name bordetella pertussis dna assay system
510(k) Number K163626
Device Name ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
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 Number866.3980
Classification Product Code
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