White Iris Leukocyte Differential Analyzer
FDA 510(k) K953116 · Intl. Remote Imaging Systems
510(k) numberK953116
Submission
- Device name
- White Iris Leukocyte Differential Analyzer
- Applicant
- Intl. Remote Imaging Systems
Chatsworth, CA, US - Received
- July 3, 1995
- Decision date
- May 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
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| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
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| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
More from Pixcell Medical Technologies
| 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 |
| 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 White Iris Leukocyte Differential Analyzer cleared by the FDA?
White Iris Leukocyte Differential Analyzer (K953116) received a 510(k) decision of Substantially Equivalent on May 13, 1996, 315 days after the submission was received.
What is the product code of K953116?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.