Mounting Media
Mounting media is a pathology laboratory reagent used to permanently affix and preserve stained tissue sections or cytological preparations on microscope slides, providing optical clarity and long-term specimen stability for histological and diagnostic review. It is classified as FDA Class 1, the lowest risk tier, and is exempt from GMP requirements. The product code is LEB, regulated under 21 CFR 864.4010, in the Pathology specialty. No premarket notification is required.
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Basic Information
- Product Code
- LEB
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842986 | REFRAX MOUNTING MEDIUM | Aug 21, 1984 | Substantially Equivalent | Anatech, Ltd. |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Apr 26, 1982 | Substantially Equivalent | Microbiological Research Corp. |
| K812193 | KOH MOUNTING FLUID | Aug 31, 1981 | Substantially Equivalent | American Scientific Products |
| K811799 | CLEAR-MOUNT | Jul 31, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K760838 | LACTO-PHENOL COTTON BLUE MOUNTING FL. | Nov 16, 1976 | Substantially Equivalent | I M, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.