BD FACSCANTO WITH BD FACSANTO SOFTWARE
FDA 510(k) clearance K041074 · decided 2004-09-17
Clearance details
- K-number
- K041074
- Device name
- BD FACSCANTO WITH BD FACSANTO SOFTWARE
- Applicant
- Bd Biosciences
- Decision
- Substantially Equivalent
- Date received
- 2004-04-26
- Decision date
- 2004-09-17
- Days to decision
- 144 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 |