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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 K262747
Device Name ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
Applicant
Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Applicant Contact Stephanie Rose
Correspondent
Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Correspondent Contact Stephanie Rose
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OOI   OZE   PGX   QWR  
Date Received08/03/2026
Decision Date 08/31/2026
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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