The following data is part of a premarket notification filed by Dna Genotek Inc with the FDA for Oragene Dx.
| Device ID | K152556 |
| 510k Number | K152556 |
| Device Name: | Oragene Dx |
| 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 | 2015-09-08 |
| Decision Date | 2016-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627595000262 | K152556 | 000 |
| 00627595000255 | K152556 | 000 |
| 00627595000248 | K152556 | 000 |
| 00627595000132 | K152556 | 000 |