LKM — Counter, Urine Particle Class II
FDA product code LKM covers "Counter, Urine Particle", a Class II medical device regulated under 21 CFR 864.5200. Submissions are reviewed by the Hematology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKM
- Device Class
- Class II
- Regulation Number
- 864.5200
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252580 | beckman coulter | iQ200 Series | September 10, 2025 |
| K232416 | arkray | AUTION EYE AI-4510 Urine Particle Analysis System | May 3, 2024 |
| K210127 | beckman coulter | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | July 2, 2021 |
| K200811 | roche diagnostics | cobas u 701 microscopy analyzer | November 6, 2020 |
| K171883 | sysmex america | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | April 23, 2018 |
| K093861 | iris international | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | February 5, 2010 |
| K083002 | sysmex america | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | February 3, 2009 |
| K080887 | sysmex america | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | May 2, 2008 |
| K070910 | sysmex america | SYSMEX MODEL UF1000I | May 25, 2007 |
| K053135 | sysmex america | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | January 4, 2006 |
| K022774 | intl. remote imaging systems | IQ 200 SYSTEM | October 21, 2002 |
| K012372 | sysmex | SYSMEX UF-50 | September 28, 2001 |
| K000373 | intl. remote imaging systems | 939UDX URINE PATHOLOGY SYSTEM | April 14, 2000 |
| K961054 | sysmex | SYSMEX UF-100 | October 28, 1996 |
| K822823 | eko scann | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | October 18, 1982 |