COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
FDA 510(k) clearance K010765 · decided 2001-04-13
Clearance details
- K-number
- K010765
- Device name
- COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-14
- Decision date
- 2001-04-13
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. HmX Hematology An recall (Z-0600-2012) | Beckman Coulter Inc. | 2012-01-11 |
| Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. H recall (Z-0601-2012) | Beckman Coulter Inc. | 2012-01-11 |
| COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hem recall (Z-2043-2011) | Beckman Coulter Inc. | 2011-04-20 |
| COULTER HmX Hematology Analyzer with Autoloader Part number: 6605525, 6605526, 6605527 The recall (Z-2044-2011) | Beckman Coulter Inc. | 2011-04-20 |
| Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology An recall (Z-1730-2011) | Beckman Coulter Inc. | 2011-03-18 |
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 |