Panels › Hematology › Product code GGT · Class 2
Assay, Erythropoietin
Regulation 864.7250
0510(k)s in 12 months (20 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in GGT
| Company | 510(k)s | Recalls |
|---|---|---|
| R&D Systems, Inc. | 3 | 1 |
| Beckman Coulter, Inc. | 2 | 1 |
| Amgen, Inc. | 2 | 0 |
| Genzyme Corp. | 2 | 0 |
| Incstar Corp. | 2 | 0 |
| Nichols Institute | 2 | 0 |
| Nichols Institute Diagnostics | 1 | 1 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 2 |
| Axis-Shield Diagnostics Limited | 1 | 0 |
| Diagnostic Products Corp. | 1 | 0 |
| 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 | K052223 |
| Mar 11, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Open, Classified |
GGT | K183088 |
| Mar 11, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica IM Erythropoietin (EPO) Assay (100 Test) Open, Classified |
GGT | K183088 |
| Jul 15, 2022 | R & D Systems, Inc. Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095 Terminated |
GGT | K931756 |
| Nov 15, 2005 | Nichols Institute Diagnostics Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512 Terminated |
GGT | None listed |
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