2XC Microscope
FDA 510(k) K822207 · Amarel Precision Instruments, Inc.
510(k) numberK822207
Submission
- Device name
- 2XC Microscope
- Applicant
- Amarel Precision Instruments, Inc.
Mchenry, IL, US - Received
- July 23, 1982
- Decision date
- August 5, 1982
- 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 |
| K874207 | The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional | Intl. Remote Imaging Systems | 01/05/1988SE |
| 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 |
| 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 |
Questions and answers
When was 2XC Microscope cleared by the FDA?
2XC Microscope (K822207) received a 510(k) decision of Substantially Equivalent on August 5, 1982, 13 days after the submission was received.
What is the product code of K822207?
The FDA product code is IBJ – Light, Microscope, a Class I (low risk) device regulated under 21 CFR 864.3600.