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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
510(k) Number K241580
Device Name Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
Applicant
Abbott Molecular
1300 E Touhy Ave
Des Plaines,  IL  60018
Applicant Contact Stacy Ferguson
Correspondent
Abbott Molecular
1300 E Touhy Ave
Des Plaines,  IL  60018
Correspondent Contact Stacy Ferguson
Regulation Number866.3981
Classification Product Code
QQX  
Subsequent Product Codes
JSM   LIO  
Date Received06/03/2024
Decision Date 12/06/2024
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
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