510(k) K183088 ยท GGT Assay, Erythropoietin
ADVIA Centaur Erythropoietin (EPO) assay
| Applicant | Axis-Shield Diagnostics Limited, Dundee, GB |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | Nov 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica IM Erythropoietin (EPO) Assay (100 Test) Open, Classified |
GGT | None listed |
| Mar 11, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Open, Classified |
GGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.