X100 with Full Field Peripheral Blood Smear (PBS) Application— 510(k) K201301
Substantially EquivalentScopio Labs , Ltd.
FDA 510(k) clearance K201301 for X100 with Full Field Peripheral Blood Smear (PBS) Application, Substantially Equivalent on 2020-10-02. Applicant: Scopio Labs , Ltd..
Clearance details
- Applicant
- Scopio Labs , Ltd.
- Product code
- Code JOY
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tel Aviv, IL
Data sourced from openFDA. This site is unofficial and independent of the FDA.