Product code LKM
- Device name
- Counter, Urine Particle
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5200
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025-09-10 |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | 2024-05-03 |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021-07-02 |
| K200811 | cobas u 701 microscopy analyzer | Roche Diagnostics | 2020-11-06 |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | 2018-04-23 |
| K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | Iris International, Inc. | 2010-02-05 |
| K083002 | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | Sysmex America, Inc. | 2009-02-03 |
| K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | Sysmex America, Inc. | 2008-05-02 |
| K070910 | SYSMEX MODEL UF1000I | Sysmex America, Inc. | 2007-05-25 |
| K053135 | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | Sysmex America, Inc. | 2006-01-04 |
| K022774 | IQ 200 SYSTEM | Intl. Remote Imaging Systems | 2002-10-21 |
| K012372 | SYSMEX UF-50 | Sysmex Corp. | 2001-09-28 |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | 2000-04-14 |
| K961054 | SYSMEX UF-100 | Sysmex Corp. | 1996-10-28 |
| K822823 | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | Eko Scann AB | 1982-10-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00015482188627 | AUTION EYE™ AI-4510 Analyzer | ARKRAY USA, INC. | 2024-12-02 |
| 04987562440139 | Fully Automated Urine Particle Analyzer UF-5000 | SYSMEX CORPORATION | 2018-05-31 |
| 10837461001256 | iQ200 | BECKMAN COULTER IRELAND INC. | 2016-09-07 |
| 10837461001300 | iQ200 | BECKMAN COULTER IRELAND INC. | 2016-09-07 |
| 10837461001317 | iQ200 | BECKMAN COULTER IRELAND INC. | 2016-09-07 |
| 10837461001355 | iQ200 | BECKMAN COULTER IRELAND INC. | 2016-09-07 |
| 10837461002192 | iQ®200 | IRIS INTERNATIONAL, INC. | 2016-09-07 |
| 04987562408542 | Fully Automated Urine Particle Analyzer UF-1000i | SYSMEX CORPORATION | 2016-08-04 |
| 00664369000639 | Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software | Sysmex America, Inc. | 2016-08-04 |