The following data is part of a premarket notification filed by Dna Genotek, Inc. with the FDA for Oragene Dx Ogd-500.001.
| Device ID | K141410 |
| 510k Number | K141410 |
| Device Name: | ORAGENE DX OGD-500.001 |
| Classification | Dna Specimen Collection, Saliva |
| Applicant | DNA GENOTEK, INC. 2 BEAVERBROOK ROAD Ottawa, CA K2k 1l1 |
| Contact | Dan Fullerton |
| Correspondent | Dan Fullerton DNA GENOTEK, INC. 2 BEAVERBROOK ROAD Ottawa, 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 | 2014-05-29 |
| Decision Date | 2015-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627595000026 | K141410 | 000 |