BD FACSCANTO SYSTEM
FDA 510(k) clearance K040725 · decided 2004-09-10
Clearance details
- K-number
- K040725
- Device name
- BD FACSCANTO SYSTEM
- Applicant
- Becton Dickinson Immunocytometry Systems
- Decision
- Substantially Equivalent
- Date received
- 2004-03-22
- Decision date
- 2004-09-10
- Days to decision
- 172 days
- Clearance type
- Traditional
- 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 |
| 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 |