510(k) K254121 · SIH Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
Colli-PeeDx Urine Collection Kit
| Applicant | DNA Genotek, Inc., Ottawa, CA |
| Decision | Substantially Equivalent, Jun 10, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254121
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.