Paraffin Embedding Medium
FDA 510(k) K810568 · Surgipath Medical Industries, Inc.
510(k) numberK810568
Submission
- Device name
- Paraffin Embedding Medium
- Applicant
- Surgipath Medical Industries, Inc.
Mchenry, IL, US - Received
- March 3, 1981
- Decision date
- March 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893772 | Tissue Embedding MediumKEO · Traditional | Stephens Scientific | 06/22/1989SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | Richard-Allan Medical Ind., Inc. | 06/17/1986SE |
| K862141 | Histology ParaffinKEO · Traditional | Erie Scientific Co. | 06/13/1986SE |
| K861270 | Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional | Surgipath Medical Industries, Inc. | 04/11/1986SE |
| K842053 | Paraplast Extra Tissue Embedding Med.KEO · Traditional | Sherwood Medical Co. | 06/26/1984SE |
| K833071 | Technicon ParacutKEO · Traditional | Technicon Instruments Corp. | 10/14/1983SE |
| K831580 | Paraffin Infiltration MediumKEO · Traditional | Surgipath Medical Industries, Inc. | 06/17/1983SE |
| K812191 | Vaspar SealentKEO · Traditional | American Scientific Products | 08/31/1981SE |
| K803241 | Histological Embedding MediaKEO · Traditional | Miles Laboratories, Inc. | 01/28/1981SE |
| K760602 | Sorvall Embedding MediumKEO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/21/1976SE |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883217 | Schiff ReagentHZT · Traditional | 08/05/1988SE |
| K881921 | C-E BrushHHT · Traditional | 07/19/1988SE |
| K881922 | Cytojars Prefilled with Cytology PreservativeLDZ · Traditional | 05/25/1988SE |
| K881659 | Tissue Section AdhesiveIFZ · Traditional | 04/21/1988SE |
| K863549 | Reusable/Disposable Autopsy Knife SetEMF · Traditional | 09/30/1986SE |
| K863616 | Knife MakerIDL · Traditional | 09/25/1986SE |
| K863548 | Rotary MicrotomeIDO · Traditional | 09/19/1986SE |
| K863483 | Cassette EmbosseerIDZ · Traditional | 09/16/1986SE |
| K863145 | Cervical ScrapersHHT · Traditional | 08/19/1986SE |
| K861270 | Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional | 04/11/1986SE |
Questions and answers
When was Paraffin Embedding Medium cleared by the FDA?
Paraffin Embedding Medium (K810568) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 14 days after the submission was received.
What is the product code of K810568?
The FDA product code is KEO – Formulations, Paraffin, All, a Class I (low risk) device regulated under 21 CFR 864.4010.