Media, Mounting, Water Soluble
Water Soluble Mounting Media are aqueous-based chemical compounds used in histology to mount stained tissue sections under coverslips on microscope slides, particularly suited for sections that must not be exposed to organic solvents, such as those containing lipid-soluble stains. 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 KEQ, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Research product code KEQ 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
- KEQ
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830515 | SCOTTS TAP WATER SUBSTITUTE CONCENTRATE | Mar 31, 1983 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K792709 | KOH MOUNTING FLUID W/GLYCEROL | Jan 24, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792703 | LACTO-PHENOL ANALINE BLUE FLUID | Jan 24, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792702 | VASPAR SEALANT | Jan 24, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K781869 | DROPPER, CEPTI-SEAL KOH SOLUTION | Nov 22, 1978 | Substantially Equivalent | Marion Laboratories, Inc. |
| K781868 | DROPPER, CEPTI-SEAL LAVTOPHENOL | Nov 22, 1978 | Substantially Equivalent | Marion Laboratories, Inc. |
| K781388 | F.A. MOUNTING MEDIUM | Aug 21, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.