BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
FDA 510(k) clearance K062087 · decided 2006-09-14
Clearance details
- K-number
- K062087
- Device name
- BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
- Applicant
- Bd Biosciences
- Decision
- Substantially Equivalent
- Date received
- 2006-07-24
- Decision date
- 2006-09-14
- Days to decision
- 52 days
- Clearance type
- Special
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto I recall (Z-2090-2015) | BD Biosciences, Systems & Reagents | 2015-07-16 |
| FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. recall (Z-1525-2008) | BD Biosciences | 2008-08-16 |
| BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number recall (Z-1530-2008) | BD Biosciences | 2008-08-08 |