510(k) K190076 ยท OYX Bcr/Abl1 Monitoring Test
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 27, 2019 |
| Received | Jan 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Cepheid Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-US-10 Open, Classified |
OYX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.