Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser— 510(k) K162897

Substantially Equivalent

Beckman Coulter

FDA 510(k) clearance K162897 for Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser, Substantially Equivalent on 2017-06-23. Applicant: Beckman Coulter.

Clearance details

Applicant: Beckman Coulter
Product code: Code OYE
Advisory panel: Hematology
Date received: 2016-10-17
Decision date: 2017-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.