Slide Stainer, Contact Type
Contact Type Slide Stainer is a laboratory instrument used in pathology that applies staining reagents to tissue sections on microscope slides through direct contact between the slide surface and the reagent delivery mechanism, automating or semi-automating the staining process. 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 KIN, regulated under 21 CFR 864.3800, within the Pathology medical specialty.
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Basic Information
- Product Code
- KIN
- 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 |
|---|---|---|---|---|
| K760032 | TEST, MONO., DIFFERENTIAL SLIDE | Aug 03, 1976 | Substantially Equivalent | Gamma Biologicals, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.