FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Oragene®Dx
K Number: K192920
·
Decision Jan 14, 2020
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
6
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- Oragene®Dx
- K Number
- K192920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DNA Genotek, Inc.
- Date Received
- October 16, 2019
- Decision Date
- January 14, 2020
- Product Code
- OYJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| OYJ | Dna Specimen Collection, Saliva | FDA class 2 | Clinical Chemistry |
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ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| DEN200040 | OMNIgene GUT Dx | Nov 3, 2021 | Unknown |
| 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 |