Colli-PeeDx Urine Collection Kit— 510(k) K254121

Name: FDA 510(k) clearance K254121
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

DNA 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.

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code SIH
Device class: Class 2
Regulation: 21 CFR 866.2920
Advisory panel: Microbiology
Date received: 2025-12-19
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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