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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 ROAD TO THE CURE
SUITE 200
SAN DIEGO,  CA  92121
Applicant Contact GREG PAYNE
Correspondent
BECTON, DICKINSON & CO.
10865 ROAD 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
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