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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Legionella, Spp., Elisa
510(k) Number K113190
Device Name TRU LEGIONELLA
Applicant
Meridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact SUSAN BOGAR
Correspondent
Meridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact SUSAN BOGAR
Regulation Number866.3300
Classification Product Code
MJH  
Date Received10/31/2011
Decision Date 02/24/2012
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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