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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 K160829
Device Name illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DRIVE
CINCINNATI,  OH  45244
Applicant Contact MICHELLE L. SMITH
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DRIVE
CINCINNATI,  OH  45244
Correspondent Contact MICHELLE L. SMITH
Regulation Number866.3980
Classification Product Code
OZX  
Subsequent Product Code
OOI  
Date Received03/25/2016
Decision Date 06/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02511262
Reviewed by Third Party No
Combination Product No
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