K243144

Substantially Equivalent

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

Applicant: Scopio Labs , Ltd.
Product code: JOY
Advisory panel: Hematology
Date received: 2024-09-30
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

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