DeviceClearance

Colli-Pee•Dx Urine Collection Kit— 510(k) K254121

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K254121 for Colli-Pee•Dx Urine Collection Kit, Substantially Equivalent on 2026-06-10. Applicant: DNA Genotek, Inc..

Clearance details

Applicant
DNA Genotek, Inc.
Product code
Code SIH
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ottawa, CA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.