Slide Stainer, Immersion Type
Immersion Type Slide Stainer is a laboratory instrument used in pathology that stains tissue sections on microscope slides by immersing the slides sequentially in containers of staining solutions and reagents, processing multiple slides simultaneously through the complete staining protocol. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIO, regulated under 21 CFR 864.3800, within the Pathology medical specialty.
Research product code KIO 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
- KIO
- Device Class
- FDA class 1
- Regulation Number
- 864.3800
- 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 |
|---|---|---|---|---|
| K890984 | LINISTAIN SLS | Apr 04, 1989 | Substantially Equivalent | Shandon, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.