939UDX Urine Pathology System
FDA 510(k) K000373 · Intl. Remote Imaging Systems
510(k) numberK000373
Submission
- Device name
- 939UDX Urine Pathology System
- Applicant
- Intl. Remote Imaging Systems
Chatsworth, CA, US - Received
- February 4, 2000
- Decision date
- April 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKM – Counter, Urine Particle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
Other 510(k)s with product code LKM
| 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 |
More from Sysmex America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K022774 | Iq 200 SystemLKM · Traditional | 10/21/2002SE |
| K972141 | The Yellow Iris Urinalysis WorkstationKQO · Traditional | 08/25/1997SE |
| K953116 | White Iris Leukocyte Differential AnalyzerGKZ · Traditional | 05/13/1996SE |
| K960054 | 900UDX Urine Pathology SystemKQO · Traditional | 03/22/1996SE |
| K954006 | Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis CapabilityGKL · Traditional | 03/12/1996SE |
| K943463 | The Yellow IrisKQO · Traditional | 09/20/1994SE |
| K934539 | The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis CapabilityGKL · Traditional | 03/30/1994SE |
| K914256 | Yellow Iris Urinalysis Wrksta W/Iriscope Bdy FluGKL · Traditional | 05/01/1992SE |
| K893530 | Iristain Formula 2, Parts 1 and 2JTS · Traditional | 06/13/1989SE |
| K874207 | The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional | 01/05/1988SE |
Questions and answers
When was 939UDX Urine Pathology System cleared by the FDA?
939UDX Urine Pathology System (K000373) received a 510(k) decision of Substantially Equivalent on April 14, 2000, 70 days after the submission was received.
What is the product code of K000373?
The FDA product code is LKM – Counter, Urine Particle, a Class II (moderate risk) device regulated under 21 CFR 864.5200.