Colli-Pee•Dx Urine Collection Kit
FDA 510(k) clearance K254121 · decided 2026-06-10
Clearance details
- K-number
- K254121
- Device name
- Colli-Pee•Dx Urine Collection Kit
- Applicant
- DNA Genotek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-19
- Decision date
- 2026-06-10
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- SIH
- Device class
- 2
- Regulation number
- 866.2920
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Ottawa, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.