# DNA Genotek, Inc.

- Location (FDA's records): Ottawa, CA
- FDA decisions: 8 (2011–2026): 7 510(k) clearances and 1 De Novo grant
- Product codes: OYJ (6), QPO (1), SIH (1)
- Predicates its devices cite: 9 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton Dickinson Vacutainer Systems: 1 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)
- Teal Health, Inc.: 1 (https://510kreport.com/company/teal-health)

## Firms that cite its devices most
- Ancestry Genomics, Inc.: 1 (https://510kreport.com/company/ancestry-genomics)

## Its most-cited devices
- K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 (2011), cited by 4
- K141410: Oragene DX Ogd-500.001 (2015), cited by 2
- K192920: Oragene®•Dx (2020), cited by 1
- K152556: Oragene Dx (2016), cited by 1

## Recent decisions
- K254121: Colli-Pee•Dx Urine Collection Kit (Jun 10, 2026)
- K212745: ORAcollect®•Dx (Oct 27, 2022)
- DEN200040: OMNIgene GUT Dx (Nov 3, 2021)
- K192920: Oragene®•Dx (Jan 14, 2020)
- K152464: ORAcollect.Dx (May 26, 2016)
- K152556: Oragene Dx (May 26, 2016)
- K141410: Oragene DX Ogd-500.001 (Feb 19, 2015)
- K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 (Dec 2, 2011)

Source page: https://510kreport.com/company/dna-genotek