FDA 510(k)
Substantially Equivalent
🇨🇦 Canada
Colli-PeeDx Urine Collection Kit
K Number: K254121
·
Decision Jun 10, 2026
Classifications
0
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
8
Review Days
173
Basic Information
- Device Name
- Colli-PeeDx Urine Collection Kit
- K Number
- K254121
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DNA Genotek, Inc.
- Date Received
- December 19, 2025
- Decision Date
- June 10, 2026
- Product Code
- SIH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Other Clearances by DNA Genotek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212745 | ORAcollect®Dx | Oct 27, 2022 | Substantially Equivalent |
| DEN200040 | OMNIgene GUT Dx | Nov 3, 2021 | Unknown |
| K192920 | Oragene®Dx | Jan 14, 2020 | Substantially Equivalent |
| K152556 | Oragene Dx | May 26, 2016 | Substantially Equivalent |
| K152464 | ORAcollect.Dx | May 26, 2016 | Substantially Equivalent |
| K141410 | ORAGENE DX OGD-500.001 | Feb 19, 2015 | Substantially Equivalent |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | Dec 2, 2011 | Substantially Equivalent |