ACCESS EPO ASSAY
FDA 510(k) clearance K052223 · decided 2006-10-06
Clearance details
- K-number
- K052223
- Device name
- ACCESS EPO ASSAY
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-15
- Decision date
- 2006-10-06
- Days to decision
- 417 days
- Clearance type
- Abbreviated
- Product code
- GGT
- Device class
- 2
- Regulation number
- 864.7250
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access EPO (K240182) | Beckman Coulter, Inc. | 2024-04-22 |
| ADVIA Centaur Erythropoietin (EPO) assay (K183088) | Axis-Shield Diagnostics Limited | 2019-08-02 |
| SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (K992799) | Sangui Biotech, Inc. | 2000-06-07 |
| IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (K983203) | Diagnostic Products Corp. | 1999-07-12 |
| ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (K980737) | Nichols Institute Diagnostics | 1999-03-23 |
| ERYTHROPOIETIN IMMUNOASSAY KIT (K952559) | Nichols Institute | 1996-05-29 |
| PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (K954898) | Genzyme Corp. | 1996-02-05 |
| QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K936016) | R&D Systems, Inc. | 1994-07-19 |
| QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (K931756) | R&D Systems, Inc. | 1994-04-21 |
| ERYTHROPOIETIN IMMUNOASSAY KIT (K932650) | Nichols Institute | 1994-03-11 |
| QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY (K931666) | R&D Systems, Inc. | 1993-07-20 |
| PREDICTA ERYTHROPOIETIN KIT (K926390) | Genzyme Corp. | 1993-06-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) prod recall (Z-1249-2025) | Beckman Coulter, Inc. | 2025-02-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |