Counter, Urine Particle
FDA product code LKM · Class II (moderate risk) · 21 CFR 864.5200 · Hematology
15510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 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 |
| K083002 | Sysmex UF-500I Automated Urine Particle AnalyzerLKM · Special | Sysmex America, Inc. | 02/03/2009SE |
| 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 |
| K012372 | Sysmex UF-50LKM · Traditional | Sysmex Corp. | 09/28/2001SE |
| K000373 | 939UDX Urine Pathology SystemLKM · Traditional | Intl. Remote Imaging Systems | 04/14/2000SE |
| K961054 | Sysmex UF-100LKM · Traditional | Sysmex Corp. | 10/28/1996SE |
| K822823 | Hematology Computer-Interface, ViscountLKM · Traditional | Eko Scann AB | 10/18/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0787-2024 Class II | iQ Waste Well Adapter, Part Number: 700-3393Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | Beckman Coulter, Inc. | 12/19/2023Open, Classified |
| Z-0786-2024 Class II | REV 2 Flowcell Capsule Spare, Part Number: C04154Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | Beckman Coulter, Inc. | 12/19/2023Open, Classified |
| Z-0785-2024 Class II | iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c)…Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | Beckman Coulter, Inc. | 12/19/2023Open, Classified |
| Z-0784-2024 Class II | Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | Beckman Coulter, Inc. | 12/19/2023Open, Classified |
| Z-0914-2020 Class II | iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325…Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen… | Beckman Coulter Inc. | 10/28/2019Terminated |
| Z-0949-2014 Class II | The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic…The current Century Break patch did not contain the same setting for the Century Break year for both the Red… | Sysmex America, Inc. | 03/31/2013Terminated |