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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K241573
Device Name Alinity m Resp-4-Plex
Applicant
Abbott Molecular Inc
1300 E Touhy Ave
Des Plaines,  IL  60018
Applicant Contact Stacy Ferguson
Correspondent
Abbott Molecular Inc
1300 E Touhy Ave
Des Plaines,  IL  60018
Correspondent Contact Stacy Ferguson
Regulation Number866.3981
Classification Product Code
QOF  
Date Received06/03/2024
Decision Date 02/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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