510(k) K212745
- Device
- ORAcollect®•Dx
- Applicant
- DNA Genotek Inc
- 510(k) number
- K212745
- Product code
- OYJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-27
- Date received
- 2021-08-30
- Regulation
- 862.1675
- Classification name
- Dna Specimen Collection, Saliva
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Austin Udocor
- Address
- 3000 - 500 Palladium Dr. Ottawa CA K2V 1C2 K2V 1C2
FDA Registration Numbers#
- 3009746061
- 3011057574
- 3005406097
- 3006413195
- 3011845225
- 3042854290
- 3022474803
- 3004597845
- 3015209536
- 3013248161
- 3001452053
- 3007699459
- 8022032
- 3004142665
- 3003742580
- 3011854984
Source Documents#
Other 510(k) Records For Product Code OYJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192947 | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | 2020-08-13 |
| K192920 | Oragene®•Dx | DNA Genotek, Inc. | 2020-01-14 |
| K152464 | ORAcollect.Dx | DNA Genotek, Inc. | 2016-05-26 |
| K152556 | Oragene Dx | DNA Genotek, Inc. | 2016-05-26 |
| K141410 | ORAGENE DX OGD-500.001 | DNA Genotek, Inc. | 2015-02-19 |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | DNA Genotek, Inc. | 2011-12-02 |
Legacy Summary#
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FDA Review#
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