Visby Medical Sexual Health Test— 510(k) K220407

Substantially Equivalent

Visby Medical

FDA 510(k) clearance K220407 for Visby Medical Sexual Health Test, Substantially Equivalent on 2023-03-07. Applicant: Visby Medical. Device class: 2.

Clearance details

Applicant: Visby Medical
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2022-02-14
Decision date: 2023-03-07
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.