FDA Product Code
FDA Product Code LKM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5200
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025-09-10 | Special | PDF ↗ |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | 2024-05-03 | Traditional | PDF ↗ |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021-07-02 | Traditional | PDF ↗ |
| K200811 | cobas u 701 microscopy analyzer | Roche Diagnostics | 2020-11-06 | Traditional | PDF ↗ |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | 2018-04-23 | Traditional | PDF ↗ |
| K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | Iris International, Inc. | 2010-02-05 | Special | PDF ↗ |
| K083002 | SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER | Sysmex America, Inc. | 2009-02-03 | Special | PDF ↗ |
| K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | Sysmex America, Inc. | 2008-05-02 | Special | PDF ↗ |
| K070910 | SYSMEX MODEL UF1000I | Sysmex America, Inc. | 2007-05-25 | Traditional | PDF ↗ |
| K053135 | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | Sysmex America, Inc. | 2006-01-04 | Traditional | PDF ↗ |
| K022774 | IQ 200 SYSTEM | Intl. Remote Imaging Systems | 2002-10-21 | Traditional | PDF ↗ |
| K012372 | SYSMEX UF-50 | Sysmex Corp. | 2001-09-28 | Traditional | PDF ↗ |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | 2000-04-14 | Traditional | PDF ↗ |
| K961054 | SYSMEX UF-100 | Sysmex Corp. | 1996-10-28 | Traditional | PDF ↗ |
| K822823 | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | Eko Scann AB | 1982-10-18 | Traditional | PDF ↗ |
Product code LKM · Class II · Hematology. Data: openFDA.