OYJ — Dna Specimen Collection, Saliva Class II
FDA product code OYJ covers "Dna Specimen Collection, Saliva", a Class II medical device regulated under 21 CFR 862.1675. Submissions are reviewed by the Clinical Chemistry panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- OYJ
- Device Class
- Class II
- Regulation Number
- 862.1675
- Submission Type
- 510(k)
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212745 | Dna Genotek | ORAcollect®Dx | Oct 27, 2022 |
| K192947 | Ancestry Genomics | AncestryDNA Saliva Collection Kit | Aug 13, 2020 |
| K192920 | Dna Genotek | Oragene®Dx | Jan 14, 2020 |
| K152556 | Dna Genotek | Oragene Dx | May 26, 2016 |
| K152464 | Dna Genotek | ORAcollect.Dx | May 26, 2016 |
| K141410 | Dna Genotek | ORAGENE DX OGD-500.001 | Feb 19, 2015 |
| K110701 | Dna Genotek | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | Dec 2, 2011 |