Access EPO
FDA 510(k) K240182 · Beckman Coulter, Inc.
510(k) numberK240182
Submission
- Device name
- Access EPO
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- January 23, 2024
- Decision date
- April 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGT – Assay, Erythropoietin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7250
- Specialty
- Hematology
Other 510(k)s with product code GGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183088 | ADVIA Centaur Erythropoietin (EPO) assayGGT · Traditional | Axis-Shield Diagnostics Limited | 08/02/2019SE |
| K052223 | Access Epo AssayGGT · Abbreviated | Beckman Coulter, Inc. | 10/06/2006SE |
| K992799 | Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitGGT · Traditional | Sangui Biotech, Inc. | 06/07/2000SE |
| K983203 | Immulite Epo, Model #'S Lkepz & LKEP1GGT · Traditional | Diagnostic Products Corp. | 07/12/1999SE |
| K980737 | Advantage Chemiluminescence Erythropoietin ImmunoassayGGT · Traditional | Nichols Institute Diagnostics | 03/23/1999SE |
| K952559 | Erythropoietin Immunoassay KitGGT · Traditional | Nichols Institute | 05/29/1996SE |
| K954898 | Predicta Erythropoietin Kit (Modification)GGT · Traditional | Genzyme Corp. | 02/05/1996SE |
| K936016 | Quantikine IVD Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)GGT · Traditional | R&D Systems, Inc. | 07/19/1994SE |
| K931756 | Quantikine(Tm) Erythropoietin Human Serum ControlsGGT · Traditional | R&D Systems, Inc. | 04/21/1994SE |
| K932650 | Erythropoietin Immunoassay KitGGT · Traditional | Nichols Institute | 03/11/1994SE |
More from Nichols Institute
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access EPO cleared by the FDA?
Access EPO (K240182) received a 510(k) decision of Substantially Equivalent on April 22, 2024, 90 days after the submission was received.
What is the product code of K240182?
The FDA product code is GGT – Assay, Erythropoietin, a Class II (moderate risk) device regulated under 21 CFR 864.7250.