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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trichomonas Vaginalis Nucleic Acid Amplification Test System
510(k) Number K231316
Device Name Aptima Trichomonas vaginalis Assay
Applicant
Hologic, Inc.
10210 Genetic Center Drive
San Diego,  CA  92121
Applicant Contact Jingwen Chen
Correspondent
Hologic, Inc.
10210 Genetic Center Drive
San Diego,  CA  92121
Correspondent Contact Jingwen Chen
Regulation Number866.3860
Classification Product Code
OUY  
Date Received05/08/2023
Decision Date 11/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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