ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I— 510(k) K102644
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K102644 for ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I, Substantially Equivalent on 2011-11-23. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- 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, through . 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.