CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
FDA 510(k) clearance K022512 · decided 2002-09-30
Clearance details
- K-number
- K022512
- Device name
- CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
- Applicant
- Immunicon Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-30
- Decision date
- 2002-09-30
- 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
- Huntingdon Valley, PA, 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 |
| COULTER CELLPREP (K021150) | Beckman Coulter, Inc. | 2002-06-11 |
| 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.