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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K254121
Device Name Colli-Pee•Dx Urine Collection Kit
Applicant
DNA Genotek, Inc.
3000 - 500 Palladium Dr.
Ottawa,  CA K2V 1C2
Applicant Contact Jonathan Chan
Correspondent
DNA Genotek, Inc.
3000 - 500 Palladium Dr.
Ottawa,  CA K2V 1C2
Correspondent Contact Jonathan Chan
Classification Product Code
SIH
Date Received12/19/2025
Decision Date 06/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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