510(k) K062087— BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

Substantially Equivalent

Bd Biosciences

Clearance details

Applicant: Bd Biosciences
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2006-07-24
Decision date: 2006-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

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.