CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
FDA 510(k) clearance K890491 · decided 1989-04-18
Clearance details
- K-number
- K890491
- Device name
- CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
- Applicant
- Abbott Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1989-01-31
- Decision date
- 1989-04-18
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott CELL-DYN 3000 Hematology Analyzer recall (Z-1198-2007) | Abbott Laboratories | 2007-08-29 |