BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)— 510(k) K141468

Substantially Equivalent

Bd Biosciences

FDA 510(k) clearance K141468 for BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration), Substantially Equivalent on 2015-02-27. Applicant: Bd Biosciences.

Clearance details

Applicant: Bd Biosciences
Product code: Code OYE
Advisory panel: Hematology
Date received: 2014-06-03
Decision date: 2015-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OYE

product code OYE

Malfunction: 828
Total: 828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.