K254121
- 510(k) number
- K254121
- Device name
- Colli-PeeDx Urine Collection Kit
- Applicant
- DNA Genotek, Inc. CA
- Product code
- SIH — Device For Home Collection And Transport Of Specimen
- Decision date
- 2026-06-10
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254121.pdf
Official FDA record: K254121
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.