FDA Product Code
FDA Product Code OYJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1675
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212745 | ORAcollect®Dx | DNA Genotek, Inc. | 2022-10-27 | Traditional | PDF ↗ |
| K192947 | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | 2020-08-13 | Traditional | PDF ↗ |
| K192920 | Oragene®Dx | DNA Genotek, Inc. | 2020-01-14 | Traditional | PDF ↗ |
| K152556 | Oragene Dx | DNA Genotek, Inc. | 2016-05-26 | Traditional | PDF ↗ |
| K152464 | ORAcollect.Dx | DNA Genotek, Inc. | 2016-05-26 | Traditional | PDF ↗ |
| K141410 | ORAGENE DX OGD-500.001 | DNA Genotek, Inc. | 2015-02-19 | Traditional | PDF ↗ |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | DNA Genotek, Inc. | 2011-12-02 | Traditional | PDF ↗ |
Product code OYJ · Class II · Clinical Chemistry. Data: openFDA.