UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM— 510(k) K081930

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K081930 for UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, Substantially Equivalent on 2008-12-19. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2008-07-07
Decision date: 2008-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Miami, FL, US

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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.