Cleared Traditional

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

K182062 · Sysmex America, Inc. · Hematology
Oct 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K182062 is an FDA 510(k) clearance for the Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on October 30, 2018, 90 days after receiving the submission on August 1, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K182062 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2018
Decision Date October 30, 2018
Days to Decision 90 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

Similar Devices — JOY Device, Automated Cell-locating

All 34
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144 · Scopio Labs , Ltd. · Jun 2025
AI100 with Shonit
K221309 · Sigtuple Technologies Pvt. , Ltd. · Sep 2023
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
K220013 · Scopio Labs , Ltd. · May 2022
CellaVision DC-1, CellaVision DC-1 PPA
K200595 · CellaVision AB · Oct 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · Scopio Labs , Ltd. · Oct 2020
Advanced RBC Application
K171315 · CellaVision AB · Aug 2017