Source document or public record
FDA 510(k) K231329 — Aptima Neisseria gonorrhoeae Assay
FDA 510(k) index record K231329. Device: Aptima Neisseria gonorrhoeae Assay. Applicant as listed: Hologic, Inc.. Decision date: 2024-01-26.
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"device_name": "Aptima Neisseria gonorrhoeae 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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2026-10-20
2026-10-20
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FDA 510(k) public index record K231329.
Device name: Aptima Neisseria gonorrhoeae Assay. Applicant as listed: Hologic, Inc..
Decision date: 2024-01-26. Decision wording: Substantially Equivalent.
Product code: LSL. Regulation: 21 CFR 866.3390. Medical specialty: Microbiology.
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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