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

Clearance details

Applicant

Beckman Coulter

Product code

Code OYE

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

2016-10-17

Decision date

2017-06-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Miami, FL, US

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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 →