510(k) K254121

Device

Colli-Pee•Dx Urine Collection Kit

Applicant

DNA Genotek, Inc.

510(k) number

K254121

Product code

SIH

Decision

Substantially Equivalent (SESE)

Decision date

2026-06-10

Date received

2025-12-19

Regulation

866.2920

Classification name

Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N