MEDONIC CA620/530 HEMATOLOGY ANALYZER— 510(k) K032214
Substantially EquivalentBoule Medical AB
FDA 510(k) clearance K032214 for MEDONIC CA620/530 HEMATOLOGY ANALYZER, Substantially Equivalent on 2004-01-29. Applicant: Boule Medical AB.
Clearance details
- Applicant
- Boule Medical AB
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plantation, FL, 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.