BD FACS SAMPLE PREP ASSISTANT III (SPA III)— 510(k) K102064

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K102064 for BD FACS SAMPLE PREP ASSISTANT III (SPA III), Substantially Equivalent on 2011-03-07. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2010-07-23
Decision date: 2011-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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.