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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
510(k) Number K221925
Device Name ID NOW COVID-19 2.0
Applicant
Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Applicant Contact Jessica E. Stahle
Correspondent
Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Correspondent Contact Jessica E. Stahle
Classification Product Code
QWR  
Date Received07/01/2022
Decision Date 08/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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