Colli-PeeDx Urine Collection Kit— 510(k) K254121
Substantially EquivalentDNA Genotek, Inc.
FDA 510(k) clearance K254121 for Colli-PeeDx Urine Collection Kit, Substantially Equivalent on 2026-06-10. Applicant: DNA Genotek, Inc.. Device class: 2.
Summary
DNA Genotek's Colli-PeeDx Urine Collection Kit is filed under SIH, devices for home collection and transport of specimens by lay users for use in a cleared non-viral STI molecular assay. The record doesn't list the kit's contents.
Class II, 21 CFR 866.2920. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
DNA Genotek filed from Ottawa, Canada. Review took 173 calendar days (December 19, 2025 to June 10, 2026).
Clearance details
- Applicant
- DNA Genotek, Inc.
- Product code
- Product code SIH
- Device class
- Class 2
- Regulation
- 21 CFR 866.2920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ottawa, CA
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