COULTER CELLPREP
FDA 510(k) clearance K021150 · decided 2002-06-11
Clearance details
- K-number
- K021150
- Device name
- COULTER CELLPREP
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-10
- Decision date
- 2002-06-11
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- GKH
- Device class
- 1
- Regulation number
- 864.5240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, 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 |
|---|---|---|
| CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (K100684) | Veridex, LLC | 2010-08-26 |
| IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077) | Immunicon Corp. | 2004-03-12 |
| CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (K022512) | Immunicon Corp. | 2002-09-30 |
| COULTER MULTI Q PREP (K935953) | Coulter Corp. | 1994-03-11 |
| COULTER MULTI-Q-PREP (K923530) | Coulter Electronics, Inc. | 1992-10-14 |
| FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (K904795) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-31 |
| SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM (K882767) | Toa Medical Electronics USA, Inc. | 1988-07-18 |
| AD150, AUTOMATED HEMATOLOGY DILUTOR (K852373) | Abbott Diagnostics | 1985-07-05 |
| HYCEL DILUTOR, VARIOUS MODELS/MULTI (K842747) | R&D Systems, Inc. | 1984-10-01 |
| DILU-MATIC 140 (K842446) | Abbott Diagnostics | 1984-09-06 |
| DILULAB 230 (K823522) | Innovative Medical Systems, Inc. | 1982-12-28 |
| ROYCO MODEL 371 SUPER DILUTOR (K791644) | Royco Instruments | 1979-09-19 |
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 |