ABBOTT CELL-DYN 4000 SYSTEM
FDA 510(k) clearance K961439 · decided 1996-10-18
Clearance details
- K-number
- K961439
- Device name
- ABBOTT CELL-DYN 4000 SYSTEM
- Applicant
- Abbott Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1996-04-15
- Decision date
- 1996-10-18
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hemato recall (Z-1623-2011) | Abbott Laboratories | 2011-03-11 |
| White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Sy recall (Z-1103-2008) | Abbott Laboratories | 2008-05-14 |
| CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed recall (Z-0708-2007) | Abbott Laboratories | 2007-04-03 |
| CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured b recall (Z-0640-2007) | Abbott Laboratories | 2007-03-17 |
| CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured b recall (Z-0639-2007) | Abbott Laboratories | 2007-03-16 |
| CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. Li recall (Z-0565-2007) | Abbott Laboratories | 2007-03-01 |
| Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73 recall (Z-0648-03) | Abbott Laboratories | 2003-03-13 |