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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 K041049
Device Name BINAXNOW INFLUENZA A & B TEST
Applicant
Binax, Inc.
217 Read St.
Portland,  ME  04103
Applicant Contact PAM ANGELL
Correspondent
Binax, Inc.
217 Read St.
Portland,  ME  04103
Correspondent Contact PAM ANGELL
Regulation Number866.3328
Classification Product Code
PSZ  
Subsequent Product Code
GNW  
Date Received04/22/2004
Decision Date 08/10/2004
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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