COULTER BODY FLUID CONTROL
FDA 510(k) clearance K082162 · decided 2009-02-03
Clearance details
- K-number
- K082162
- Device name
- COULTER BODY FLUID CONTROL
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-31
- Decision date
- 2009-02-03
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- JPK
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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| XN CHECK BF (K160588) | Streck | 2016-12-22 |
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| BC-5D Hematology Control (K160606) | R&D Systems, Inc. | 2016-09-01 |
| XN CHECK (K141964) | Streck | 2014-12-05 |
| XN CHECK BF (K141957) | Streck | 2014-12-05 |
| R&D 5D RETIC HEMATOLOGY CONTROL (K130962) | R&D Systems, Inc. | 2013-07-24 |
| XN CHECK BF (K120744) | Streck | 2012-10-19 |
| XN CHECK (K120742) | Streck | 2012-10-19 |
| R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (K101578) | R&D Systems, Inc. | 2011-04-28 |
| COULTER LIN-X LINEARITY CONTROL, MODEL A81196 (K100790) | Beckman Coulter, Inc. | 2010-12-21 |
| COULTER 4C-EX 300 CELL CONTROL (K100607) | Beckman Coulter, Inc. | 2010-11-18 |
Recalls involving this device
No recalls on record reference this clearance.
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 |