510(k) K090346— ADVIA 2120/2120I BODY FLUIDS

Substantially Equivalent

Siemens Healthcare Diagnostics

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2009-02-11
Decision date: 2010-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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.