CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
FDA 510(k) clearance K852371 · decided 1985-09-17
Clearance details
- K-number
- K852371
- Device name
- CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
- Applicant
- Abbott Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1985-06-04
- Decision date
- 1985-09-17
- Days to decision
- 105 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
No recalls on record reference this clearance.