SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER— 510(k) K051459

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K051459 for SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER, Substantially Equivalent on 2005-09-23. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2005-06-02
Decision date: 2005-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, 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.