The Purple Iris(Tm) Cytopathology Workstation
FDA 510(k) K874207 · Intl. Remote Imaging Systems
510(k) numberK874207
Submission
- Device name
- The Purple Iris(Tm) Cytopathology Workstation
- Applicant
- Intl. Remote Imaging Systems
Chatsworth, CA, US - Received
- October 15, 1987
- Decision date
- January 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IBJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874750 | Video Analyzer 4000IBJ · Traditional | Scientific Imaging, Inc. | 04/25/1988SE |
| K874190 | Cell Counting Grid GraticuleIBJ · Traditional | Portable Medical Laboratories, Inc. | 01/05/1988SE |
| K864049 | Mcarthur Microscope, Standard Metal VersionIBJ · Traditional | Portable Medical Laboratories, Inc. | 10/29/1986SE |
| K854735 | Mcarthur Microscope Plastic Version with Acc.IBJ · Traditional | Portable Medical Laboratories, Inc. | 12/10/1985SE |
| K823040 | Pathology Instrumentation & AccessoriesIBJ · Traditional | Iris Remote Imaging Systems | 01/14/1983SE |
| K822207 | 2XC MicroscopeIBJ · Traditional | Amarel Precision Instruments, Inc. | 08/05/1982SE |
| K821865 | A O Microscope Video SystemIBJ · Traditional | Warner-Lambert Co. | 07/14/1982SE |
| K802818 | Pullen Pocket ScopeIBJ · Traditional | P.A. Research Corp. | 04/17/1981SE |
More from P.A. Research 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 |
| 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 |
Questions and answers
When was The Purple Iris(Tm) Cytopathology Workstation cleared by the FDA?
The Purple Iris(Tm) Cytopathology Workstation (K874207) received a 510(k) decision of Substantially Equivalent on January 5, 1988, 82 days after the submission was received.
What is the product code of K874207?
The FDA product code is IBJ – Light, Microscope, a Class I (low risk) device regulated under 21 CFR 864.3600.