Counter, Urine Particle
Counter, Urine Particle is an automated instrument used to enumerate and characterize formed elements in urine such as red blood cells, white blood cells, casts, and other particles, supporting urinalysis in clinical hematology laboratories. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKM, regulated under 21 CFR 864.5200, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- LKM
- Device Class
- FDA class 2
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252580 | iQ200 Series | Sep 10, 2025 | Substantially Equivalent | Beckman Coulter, Inc. |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | May 03, 2024 | Substantially Equivalent | Arkray, Inc. |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Jul 02, 2021 | Substantially Equivalent | Beckman Coulter, Inc. |
| K200811 | cobas u 701 microscopy analyzer | Nov 06, 2020 | Substantially Equivalent | Roche Diagnostics |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Apr 23, 2018 | Substantially Equivalent | Sysmex America, Inc. |
| K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | Feb 05, 2010 | Substantially Equivalent | Iris International, Inc. |
| K083002 | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | Feb 03, 2009 | Substantially Equivalent | Sysmex America, Inc. |
| K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | May 02, 2008 | Substantially Equivalent | Sysmex America, Inc. |
| K070910 | SYSMEX MODEL UF1000I | May 25, 2007 | Substantially Equivalent | Sysmex America, Inc. |
| K053135 | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | Jan 04, 2006 | Substantially Equivalent | Sysmex America, Inc. |
| K022774 | IQ 200 SYSTEM | Oct 21, 2002 | Substantially Equivalent | Intl. Remote Imaging Systems |
| K012372 | SYSMEX UF-50 | Sep 28, 2001 | Substantially Equivalent | Sysmex Corp. |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | Apr 14, 2000 | Substantially Equivalent | Intl. Remote Imaging Systems |
| K961054 | SYSMEX UF-100 | Oct 28, 1996 | Substantially Equivalent | Sysmex Corp. |
| K822823 | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | Oct 18, 1982 | Substantially Equivalent | Eko Scann AB |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.