The following data is part of a premarket notification filed by Dna Genotek Inc with the FDA for Oragene-dx Ogd-500; Oragene-dx Ogd-575; Oragene-dx Oxd-525; Oragene-dx Oyd-500.
| Device ID | K110701 |
| 510k Number | K110701 |
| Device Name: | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 |
| Classification | Dna Specimen Collection, Saliva |
| Applicant | DNA GENOTEK INC 2 BEAVERBROOK ROAD Ottawa Ontario, CA K2k 1l1 |
| Contact | Chantal Hemens-davis |
| Correspondent | Chantal Hemens-davis DNA GENOTEK INC 2 BEAVERBROOK ROAD Ottawa Ontario, CA K2k 1l1 |
| Product Code | OYJ |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627595000224 | K110701 | 000 |
| 00627595000019 | K110701 | 000 |