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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 K042472
Device Name BD DIRECTIGEN EZ FLU A + B
Applicant
Becton, Dickinson & CO
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Applicant Contact GREG PAYNE
Correspondent
Becton, Dickinson & CO
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Correspondent Contact GREG PAYNE
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received09/10/2004
Decision Date 07/07/2005
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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