The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability
FDA 510(k) K934539 · Intl. Remote Imaging Systems
510(k) numberK934539
Submission
- Device name
- The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability
- Applicant
- Intl. Remote Imaging Systems
Chatsworth, CA, US - Received
- September 17, 1993
- Decision date
- March 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
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| K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional | Bayer Healthcare, LLC | 12/07/2005SE |
| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
| K032677 | Sysmex POCH-100IGKL · Traditional | Sysmex America, Inc. | 02/11/2004SE |
| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | Bayer Diagnostics Corp. | 09/11/2002SE |
| K001683 | Sysmex R-500GKL · Traditional | Sysmex Corporation of America | 08/21/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | Coulter Corp. | 05/11/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | Sysmex Corp. | 11/03/1998SE |
More from Sysmex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K022774 | Iq 200 SystemLKM · Traditional | 10/21/2002SE |
| K000373 | 939UDX Urine Pathology SystemLKM · Traditional | 04/14/2000SE |
| 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 |
| 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 The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability cleared by the FDA?
The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability (K934539) received a 510(k) decision of Substantially Equivalent on March 30, 1994, 194 days after the submission was received.
What is the product code of K934539?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.