Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis Capability
FDA 510(k) K954006 · Intl. Remote Imaging Systems
510(k) numberK954006
Submission
- Device name
- Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis Capability
- Applicant
- Intl. Remote Imaging Systems
Chatsworth, CA, US - Received
- August 25, 1995
- Decision date
- March 12, 1996
- 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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|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter SystemGKL · Traditional | Advanced Instruments, Inc. | 05/27/2016SE |
| K091539 | Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional | Iris Diagnostics | 08/31/2010SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | Hemocue AB | 10/25/2007SE |
| 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 |
| 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 Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis Capability cleared by the FDA?
Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis Capability (K954006) received a 510(k) decision of Substantially Equivalent on March 12, 1996, 200 days after the submission was received.
What is the product code of K954006?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.