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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antigen, cf (including cf controls), respiratory syncytial virus
510(k) Number K032166
Device Name BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
Applicant
BINAX, INC.
217 READ ST.
PORTLAND,  ME  04103
Applicant Contact PAMELA ANGELL
Correspondent
BINAX, INC.
217 READ ST.
PORTLAND,  ME  04103
Correspondent Contact PAMELA ANGELL
Regulation Number866.3480
Classification Product Code
GQG  
Date Received07/16/2003
Decision Date 10/21/2003
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
Recalls CDRH Recalls
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