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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K171792
Device Name Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Applicant
Alere Scarborough, Inc.
10 Southgate Road
scarborough,  ME  04074
Applicant Contact angela drysdale
Correspondent
Alere Scarborough, Inc.
10 Southgate Road
scarborough,  ME  04074
Correspondent Contact angela drysdale
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OOI   OZE  
Date Received06/16/2017
Decision Date 09/29/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
CLIA Waiver CLIA Waiver Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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