CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
FDA 510(k) clearance K870233 · decided 1987-03-17
Clearance details
- K-number
- K870233
- Device name
- CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
- Applicant
- Abbott Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1987-01-21
- Decision date
- 1987-03-17
- Days to decision
- 55 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 |
|---|---|---|
| The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are compone recall (Z-1698-2011) | Abbott Laboratories | 2011-03-17 |
| CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa recall (Z-1628-2010) | Abbott Laboratories | 2010-05-20 |
| CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott recall (Z-1629-2010) | Abbott Laboratories | 2010-05-20 |
| CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled recall (Z-1170-2007) | Abbott Laboratories | 2007-08-18 |
| Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, recall (Z-1171-2007) | Abbott Laboratories | 2007-08-18 |