BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
FDA 510(k) clearance K141468 · decided 2015-02-27
Clearance details
- K-number
- K141468
- Device name
- BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
- Applicant
- Bd Biosciences
- Decision
- Substantially Equivalent
- Date received
- 2014-06-03
- Decision date
- 2015-02-27
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- OYE
- 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
No recalls on record reference this clearance.