510(k) K152464 ยท OYJ Dna Specimen Collection, Saliva
ORAcollect.Dx
| Applicant | DNA Genotek, Inc., Ottawa, CA |
| Decision | Substantially Equivalent, May 26, 2016 |
| Received | Aug 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152464
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2022 | DNA Genotek Inc. ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers:
OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.02 Open, Classified |
OYJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.