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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 K181853
Device Name Alere BinaxNOW Influenza A & B Card 2, Alere Reader
Applicant
Alere Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Applicant Contact Angela Drysdale
Correspondent
Alere Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Correspondent Contact Angela Drysdale
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received07/11/2018
Decision Date 08/08/2018
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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