ORAcollect®•Dx
Dna Specimen Collection, Saliva
DNA Genotek Inc
The following data is part of a premarket notification filed by Dna Genotek Inc with the FDA for Oracollect®•dx.
Pre-market Notification Details
| Device ID | K212745 |
| 510k Number | K212745 |
| Device Name: | ORAcollect®•Dx |
| Classification | Dna Specimen Collection, Saliva |
| Applicant | DNA Genotek Inc 3000 - 500 Palladium Drive Ottawa, CA K2V 1C2 |
| Contact | Austin Udocor |
| Correspondent | Jonathan Chan DNA Genotek Inc 3000 - 500 Palladium Drive Ottawa, CA K2V 1C2 |
| Product Code | OYJ |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-30 |
| Decision Date | 2022-10-27 |
Trademark Results [ORAcollect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORACOLLECT 85375308 4669396 Live/Registered |
DNA Genotek Inc. 2011-07-19 |
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