Cleared Traditional

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

K243144 · Scopio Labs , Ltd. · Hematology
Jun 2025
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K243144 is an FDA 510(k) clearance for the X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Scopio Labs , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K243144 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date June 27, 2025
Days to Decision 270 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOY — Device, Automated Cell-locating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260

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