Media, Mounting, Oil Soluble
Oil Soluble Mounting Media are chemical compounds used in histology to permanently affix stained tissue sections under coverslips on microscope slides, preserving specimens and optical clarity for long-term archival and microscopic examination. 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 KEP, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KEP
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830659 | CLEARIUM, MOUNTING MEDIUM | Mar 17, 1983 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K810323 | ACRYTOL, MOUNTING MEDIUM | Mar 06, 1981 | Substantially Equivalent | Surgipath |
| K800847 | ENTELLAN | May 08, 1980 | Substantially Equivalent | Mcb Manufacturing Chemists, 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.