510(k) K181661 ยท OYX Bcr/Abl1 Monitoring Test
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
| Applicant | Bio-Rad Laboratories, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 13, 2019 |
| Received | Jun 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2024 | Bio-Rad Laboratories Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit Open, Classified |
OYX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.