510(k) K181475— DxH 520 Hematology Instrument
UnknownBeckman Coulter
Clearance details
- Applicant
- Beckman Coulter
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Miami, 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.