HemoScreen Hematology Analyzer— 510(k) K240636
Substantially EquivalentPixcell Medical Technologies
FDA 510(k) clearance K240636 for HemoScreen Hematology Analyzer, Substantially Equivalent on 2024-05-02. Applicant: Pixcell Medical Technologies.
Clearance details
- Applicant
- Pixcell Medical Technologies
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Yokneam Ilit, IL
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.