Sysmex UF-500I Automated Urine Particle Analyzer
FDA 510(k) K083002 · Sysmex America, Inc.
510(k) numberK083002
Submission
- Device name
- Sysmex UF-500I Automated Urine Particle Analyzer
- Applicant
- Sysmex America, Inc.
Mundelein, IL, US - Received
- October 8, 2008
- Decision date
- February 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKM – Counter, Urine Particle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
Other 510(k)s with product code LKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252580 | iQ200 SeriesLKM · Special | Beckman Coulter, Inc. | 09/10/2025SE |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis SystemLKM · Traditional | Arkray, Inc. | 05/03/2024SE |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemLKM · Traditional | Beckman Coulter, Inc. | 07/02/2021SE |
| K200811 | cobas u 701 microscopy analyzerLKM · Traditional | Roche Diagnostics | 11/06/2020SE |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional | Sysmex America, Inc. | 04/23/2018SE |
| K093861 | Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina CradleLKM · Special | Iris International, Inc. | 02/05/2010SE |
| K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareLKM · Special | Sysmex America, Inc. | 05/02/2008SE |
| K070910 | Sysmex Model UF1000ILKM · Traditional | Sysmex America, Inc. | 05/25/2007SE |
| K053135 | Sysmex UF-100I Automated Urine Cell AnalyzerLKM · Traditional | Sysmex America, Inc. | 01/04/2006SE |
| K022774 | Iq 200 SystemLKM · Traditional | Intl. Remote Imaging Systems | 10/21/2002SE |
More from Intl. Remote Imaging Systems
| 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 |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional | 10/30/2018SE |
| 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 |
Questions and answers
When was Sysmex UF-500I Automated Urine Particle Analyzer cleared by the FDA?
Sysmex UF-500I Automated Urine Particle Analyzer (K083002) received a 510(k) decision of Substantially Equivalent on February 3, 2009, 118 days after the submission was received.
What is the product code of K083002?
The FDA product code is LKM – Counter, Urine Particle, a Class II (moderate risk) device regulated under 21 CFR 864.5200.