Documento fuente o registro público
FDA 510(k) K220407 — Visby Medical Sexual Health Test
FDA 510(k) index record K220407. Device: Visby Medical Sexual Health Test. Applicant as listed: Visby Medical. Decision date: 2023-03-07.
Fuente
"device_name": "Visby Medical Sexual Health Test"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-29
professional use
FDA 510(k) public index record K220407.
Device name: Visby Medical Sexual Health Test. Applicant as listed: Visby Medical.
Decision date: 2023-03-07. Decision wording: Substantially Equivalent.
Product code: QEP. Regulation: 21 CFR 866.3393. 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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