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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 K152800
Device Name illumigene Mycoplasma DNA Amplification Assay
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DRIVE
CINCINNATI,  OH  45244
Applicant Contact Stefanie Johns
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DRIVE
CINCINNATI,  OH  45244
Correspondent Contact Stefanie Johns
Regulation Number866.3980
Classification Product Code
OZX  
Date Received09/28/2015
Decision Date 10/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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