Stages, Microscope
Microscope stages are mechanical platforms mounted on laboratory microscopes that hold and allow precise positioning of specimen slides during examination, enabling the pathologist or laboratory scientist to systematically scan tissue sections or cytological preparations. They are classified as FDA Class 1 devices, the lowest risk category, subject only to general controls. Product code KEJ is regulated under 21 CFR 864.3600 in the Pathology medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.
Research product code KEJ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KEJ
- Device Class
- FDA class 1
- Regulation Number
- 864.3600
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881467 | MICROSCOPE STAGE HEATER | Apr 18, 1988 | Substantially Equivalent | Cryodyne Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.