Source document or public record
FDA 510(k) K231316 — Aptima Trichomonas vaginalis Assay
FDA 510(k) index record K231316. Device: Aptima Trichomonas vaginalis Assay. Applicant as listed: Hologic, Inc.. Decision date: 2023-11-06.
Source
"device_name": "Aptima Trichomonas vaginalis Assay"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K231316.
Device name: Aptima Trichomonas vaginalis Assay. Applicant as listed: Hologic, Inc..
Decision date: 2023-11-06. Decision wording: Substantially Equivalent.
Product code: OUY. Regulation: 21 CFR 866.3860. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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