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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 K133673
Device Name ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Dr
cincinnati,  OH  45244
Applicant Contact michelle l smith
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Dr
cincinnati,  OH  45244
Correspondent Contact michelle l smith
Regulation Number866.3980
Classification Product Code
OZZ  
Date Received11/29/2013
Decision Date 03/25/2014
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
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