FDA 510(k)
FDA class 2
Unknown
🇨🇦 Canada
OMNIgene GUT Dx
K Number: DEN200040
·
Decision Nov 3, 2021
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
8
Review Days
506
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Basic Information
- Device Name
- OMNIgene GUT Dx
- K Number
- DEN200040
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.2952
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- DNA Genotek, Inc.
- Date Received
- June 15, 2020
- Decision Date
- November 3, 2021
- Product Code
- QPO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | FDA class 2 | Microbiology |
Other Clearances by DNA Genotek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254121 | Colli-PeeDx Urine Collection Kit | Jun 10, 2026 | Substantially Equivalent |
| K212745 | ORAcollect®Dx | Oct 27, 2022 | Substantially Equivalent |
| 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 |