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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 K220801
Device Name ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Applicant
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough,  ME  04074
Applicant Contact Jessica Stahle
Correspondent
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough,  ME  04074
Correspondent Contact Jessica Stahle
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
OCC   OOI   PGX  
Date Received03/18/2022
Decision Date 06/24/2022
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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