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510(k) DEN240020

Visby Medical Women's Sexual Health Test by Visby Medical, Inc. — Product Code SEA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 28, 2025
Date Received
May 13, 2024
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Device Class
Class II
Regulation Number
866.3386
Review Panel
MI
Submission Type

This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use.

Other clearances by Visby Medical, Inc.

  • K251501 — Visby Medical Men's Sexual Health Test (October 1, 2025)
  • K242526 — Visby Medical Respiratory Health Test (February 19, 2025)
  • K220407 — Visby Medical Sexual Health Test (March 7, 2023)
  • K200748 — Visby Medical Sexual Health (August 26, 2021)