Dna Specimen Collection, Saliva
The DNA Specimen Collection, Saliva device is a non-invasive collection device intended for the collection of saliva samples for subsequent clinical DNA testing applications. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYJ, with regulation number 862.1675 under the Clinical Chemistry medical specialty.
Research product code OYJ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OYJ
- Device Class
- FDA class 2
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212745 | ORAcollect®Dx | Oct 27, 2022 | Substantially Equivalent | DNA Genotek, Inc. |
| K192947 | AncestryDNA Saliva Collection Kit | Aug 13, 2020 | Substantially Equivalent | Ancestry Genomics, Inc. |
| K192920 | Oragene®Dx | Jan 14, 2020 | Substantially Equivalent | DNA Genotek, Inc. |
| K152556 | Oragene Dx | May 26, 2016 | Substantially Equivalent | DNA Genotek, Inc. |
| K152464 | ORAcollect.Dx | May 26, 2016 | Substantially Equivalent | DNA Genotek, Inc. |
| K141410 | ORAGENE DX OGD-500.001 | Feb 19, 2015 | Substantially Equivalent | DNA Genotek, Inc. |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | Dec 02, 2011 | Substantially Equivalent | DNA Genotek, Inc. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.