Oragene®•Dx
FDA 510(k) clearance K192920 · decided 2020-01-14
Clearance details
- K-number
- K192920
- Device name
- Oragene®•Dx
- Applicant
- DNA Genotek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-16
- Decision date
- 2020-01-14
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OYJ
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ottawa, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORAcollect®•Dx (K212745) | DNA Genotek, Inc. | 2022-10-27 |
| AncestryDNA Saliva Collection Kit (K192947) | Ancestry Genomics, Inc. | 2020-08-13 |
| ORAcollect.Dx (K152464) | DNA Genotek, Inc. | 2016-05-26 |
| Oragene Dx (K152556) | DNA Genotek, Inc. | 2016-05-26 |
| ORAGENE DX OGD-500.001 (K141410) | DNA Genotek, Inc. | 2015-02-19 |
| ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 (K110701) | DNA Genotek, Inc. | 2011-12-02 |
Recalls involving this device
No recalls on record reference this clearance.