CELL-DYN EMERALD SYSTEM
FDA 510(k) clearance K081495 · decided 2009-02-04
Clearance details
- K-number
- K081495
- Device name
- CELL-DYN EMERALD SYSTEM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2008-05-29
- Decision date
- 2009-02-04
- Days to decision
- 251 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 Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Em recall (Z-1522-2016) | Abbott Laboratories | 2016-04-19 |
| Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The prod recall (Z-1733-2011) | Abbott Laboratories | 2011-03-18 |
| Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is ma recall (Z-1668-2011) | Abbott Laboratories | 2011-03-17 |
| Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: recall (Z-1094-2011) | Abbott Laboratories | 2011-02-10 |
| CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnos recall (Z-0065-2010) | Abbott Laboratories | 2009-10-19 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |