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

Name: FDA 510(k) clearance K162414
Creator: U.S. Food and Drug Administration
Published: 2016-11-29

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.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
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 ↗

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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.