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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 K021646
Device Name BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
Applicant
Binax, Inc.
217 Read St.
Portland,  ME  04103
Applicant Contact Anne Jepson
Correspondent
Binax, Inc.
217 Read St.
Portland,  ME  04103
Correspondent Contact Anne Jepson
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received05/20/2002
Decision Date 09/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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