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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 K021687
Device Name BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY 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 Number866.3480
Classification Product Code
GQG  
Date Received05/22/2002
Decision Date 09/13/2002
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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