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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 K162642
Device Name Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Applicant
ALERE SCARBOROUGH, INC.
10 SOUTHGATE ROAD
SCARBOROUGH,  ME  04074
Applicant Contact SARA HALLOWELL
Correspondent
ALERE SCARBOROUGH, INC.
10 SOUTHGATE ROAD
SCARBOROUGH,  ME  04074
Correspondent Contact SARA HALLOWELL
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received09/22/2016
Decision Date 04/10/2017
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
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