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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K071657
Device Name TRU FLU
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 Number866.3328
Classification Product Code
PSZ  
Date Received06/18/2007
Decision Date 11/15/2007
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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