DeviceClearance

K162897

Substantially Equivalent

Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser

Applicant
Beckman Coulter
Product code
OYE
Advisory panel
Hematology
Date received
Decision date
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, through . 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.