Formulations, Paraffin, All
Paraffin Formulations (All) are histological embedding media composed of paraffin wax blends used to infiltrate and surround tissue specimens, providing the rigid support matrix necessary for thin section cutting on a microtome. 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 KEO, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Basic Information
- Product Code
- KEO
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893772 | TISSUE EMBEDDING MEDIUM | Jun 22, 1989 | Substantially Equivalent | Stephens Scientific |
| K862223 | MICRO THIN* PARAFFIN | Jun 17, 1986 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K862141 | HISTOLOGY PARAFFIN | Jun 13, 1986 | Substantially Equivalent | Erie Scientific Co. |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | Apr 11, 1986 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K842053 | PARAPLAST EXTRA TISSUE EMBEDDING MED. | Jun 26, 1984 | Substantially Equivalent | Sherwood Medical Co. |
| K833071 | TECHNICON PARACUT | Oct 14, 1983 | Substantially Equivalent | Technicon Instruments Corp. |
| K831580 | PARAFFIN INFILTRATION MEDIUM | Jun 17, 1983 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K812191 | VASPAR SEALENT | Aug 31, 1981 | Substantially Equivalent | American Scientific Products |
| K810568 | PARAFFIN EMBEDDING MEDIUM | Mar 17, 1981 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K803241 | HISTOLOGICAL EMBEDDING MEDIA | Jan 28, 1981 | Substantially Equivalent | Miles Laboratories, Inc. |
| K760602 | SORVALL EMBEDDING MEDIUM | Sep 21, 1976 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.