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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name influenza a and influenza b multiplex nucleic acid assay
510(k) Number K190204
Device Name ID NOW Influenza A & B 2
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
OZE  
Subsequent Product Codes
OCC   OOI  
Date Received02/04/2019
Decision Date 03/18/2019
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
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