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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 K243396
Device Name Aptima SARS-CoV-2 Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Applicant Contact Katerina Capkova
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Correspondent Contact Katerina Capkova
Regulation Number866.3981
Classification Product Code
QQX  
Subsequent Product Code
NSU  
Date Received10/31/2024
Decision Date 02/13/2025
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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