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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mycoplasma Pneumoniae Dna Assay System
510(k) Number K123423
Device Name ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
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
OZX  
Subsequent Product Code
OOI  
Date Received11/06/2012
Decision Date 06/05/2013
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
Predetermined Change
Control Plan Authorized		 No
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