Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
FDA 510(k) K182062 · Sysmex America, Inc.
510(k) numberK182062
Submission
- Device name
- Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
- Applicant
- Sysmex America, Inc.
Lincolnshire, IL, US - Received
- August 1, 2018
- Decision date
- October 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOY – Device, Automated Cell-Locating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5260
- Specialty
- Hematology
Other 510(k)s with product code JOY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional | Scopio Labs , Ltd. | 06/27/2025SE |
| K221309 | AI100 with ShonitJOY · Traditional | Sigtuple Technologies Pvt. , Ltd. | 09/19/2023SE |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional | Scopio Labs , Ltd. | 05/03/2022SE |
| K200595 | CellaVision DC-1, CellaVision DC-1 PPAJOY · Traditional | CellaVision AB | 10/16/2020SE |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional | Scopio Labs , Ltd. | 10/02/2020SE |
| K171315 | Advanced RBC ApplicationJOY · Traditional | CellaVision AB | 08/01/2017SE |
| K102778 | Cellavision DM1200 with the Body Fluid ApplictionJOY · Traditional | CellaVision AB | 09/16/2011SE |
| K092116 | Easycell Cell LocatorJOY · Traditional | Medica Corp. | 05/12/2010SE |
| K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127JOY · Special | CellaVision AB | 11/20/2009SE |
| K080595 | Cellavision DM96 with the Body Fluid ApplicationJOY · Traditional | CellaVision AB | 12/05/2008SE |
More from CellaVision AB
| 510(k) | Device | Decision |
|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | 05/27/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional | 06/02/2025SE |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional | 12/21/2023SE |
| K210346 | Sysmex XW-100 Automated Hematology AnalyzerGKZ · Dual Track | 11/08/2022SE |
| K182389 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | 01/25/2019SE |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional | 04/23/2018SE |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ · Dual Track | 11/06/2017SE |
| K160538 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | 12/22/2016SE |
Questions and answers
When was Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device cleared by the FDA?
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (K182062) received a 510(k) decision of Substantially Equivalent on October 30, 2018, 90 days after the submission was received.
What is the product code of K182062?
The FDA product code is JOY – Device, Automated Cell-Locating, a Class II (moderate risk) device regulated under 21 CFR 864.5260.