K212745 is an FDA 510(k) clearance for the ORAcollect®•Dx. This device is classified as a Dna Specimen Collection, Saliva (Class II - Special Controls, product code OYJ).
Submitted by DNA Genotek, Inc. (Ottawa, CA). The FDA issued a Cleared decision on October 27, 2022, 423 days after receiving the submission on August 30, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675. A Collection Device Intended For Use In The Non-invasive Collection Of Saliva Samples For Clinical Dna Testing..
| 510(k) Number | K212745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2021 |
| Decision Date | October 27, 2022 |
| Days to Decision | 423 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | OYJ - Dna Specimen Collection, Saliva |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
| Definition | A Collection Device Intended For Use In The Non-invasive Collection Of Saliva Samples For Clinical Dna Testing. |