X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application— 510(k) K220013

Substantially Equivalent

Scopio Labs , Ltd.

FDA 510(k) clearance K220013 for X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application, Substantially Equivalent on 2022-05-03. Applicant: Scopio Labs , Ltd..

Clearance details

Applicant: Scopio Labs , Ltd.
Product code: Code JOY
Advisory panel: Hematology
Date received: 2022-01-04
Decision date: 2022-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.