OYJ
7 FDA 510(k) clearances · Product code
266 daysmedian time to decision
423 days90th percentile
7clearances measured
FDA profile
- Official device name
- Dna Specimen Collection, Saliva
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Medical specialty
- Clinical Chemistry
- FDA definition
- A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ORAcollect®•Dx (K212745) | DNA Genotek, Inc. | 2022-10-27 |
| AncestryDNA Saliva Collection Kit (K192947) | Ancestry Genomics, Inc. | 2020-08-13 |
| Oragene®•Dx (K192920) | DNA Genotek, Inc. | 2020-01-14 |
| 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 |
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Every clearance here is in the API, with alerts when new ones post.