Cleared Traditional

X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

K220013 · Scopio Labs , Ltd. · Hematology
May 2022
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K220013 is an FDA 510(k) clearance for the X100HT with Slide Loader 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 May 3, 2022, 119 days after receiving the submission on January 4, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K220013 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2022
Decision Date May 03, 2022
Days to Decision 119 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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