OYJ — Dna Specimen Collection, Saliva Class II
Classification Details
- Product Code
- OYJ
- Device Class
- Class II
- Regulation Number
- 862.1675
- Submission Type
- 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 | October 27, 2022 |
| K192947 | ancestry genomics | AncestryDNA Saliva Collection Kit | August 13, 2020 |
| K192920 | dna genotek | Oragene®Dx | January 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 | February 19, 2015 |
| K110701 | dna genotek | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | December 2, 2011 |