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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 K152285
Device Name illumigene Pertussis DNA Amplification Assay
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Dr
CINCINNATI,  OH  45244
Applicant Contact SUSAN ROLIH
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Dr
CINCINNATI,  OH  45244
Correspondent Contact SUSAN ROLIH
Regulation Number866.3980
Classification Product Code
OZZ  
Date Received08/12/2015
Decision Date 11/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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