X100 with Full Field Peripheral Blood Smear (PBS) Application— 510(k) K201301

Name: FDA 510(k) clearance K201301
Creator: U.S. Food and Drug Administration
Published: 2020-10-02

Substantially Equivalent

Scopio 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.. Device class: 2.

Clearance details

Applicant: Scopio Labs , Ltd.
Product code: Code JOY
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 2020-05-15
Decision date: 2020-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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