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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
510(k) Number K243345
Device Name Aptima BV Assay; Aptima CV/TV Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr
San Diego,  CA  92121
Applicant Contact Gabriela McCoole
Correspondent
Hologic, Inc.
10210 Genetic Center Dr
San Diego,  CA  92121
Correspondent Contact Gabriela McCoole
Classification Product Code
PQA  
Subsequent Product Codes
NSU   PMN  
Date Received10/28/2024
Decision Date 11/25/2024
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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