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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 K001364
Device Name BD DIRECTIGEN FLU A+B
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
7 LOVETON CIRCLE
SPARKS,  MD  21152 -0999
Applicant Contact Monica Giguere
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
7 LOVETON CIRCLE
SPARKS,  MD  21152 -0999
Correspondent Contact Monica Giguere
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received05/01/2000
Decision Date 06/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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