510(k) K052223 ยท GGT Assay, Erythropoietin
ACCESS EPO ASSAY
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Oct 6, 2006 |
| Received | Aug 15, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052223
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2025 | Beckman Coulter, Inc. Access Erythropoietin (EPO), Catalog Number - A16364
a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)
in Open, Classified |
GGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.