UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System— 510(k) K162414

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K162414 for UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System, Substantially Equivalent on 2016-11-29. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2016-08-29
Decision date: 2016-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, 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.