SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I— 510(k) K021241
Substantially EquivalentSysmex Corporation of America
FDA 510(k) clearance K021241 for SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I, Substantially Equivalent on 2002-06-25. Applicant: Sysmex Corporation of America.
Clearance details
- Applicant
- Sysmex Corporation of America
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Long Grove, IL, 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.