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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
510(k) Number K133411
Device Name ALERE BINAXNOW INFLUENZA A & B CARD
Applicant
Alere Scarborough, Inc D/B/A Binax, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Applicant Contact Angela Drysdale
Correspondent
Alere Scarborough, Inc D/B/A Binax, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Correspondent Contact Angela Drysdale
Regulation Number866.3330
Classification Product Code
GNX  
Date Received11/07/2013
Decision Date 12/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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