Histology Paraffin
FDA 510(k) K862141 · Erie Scientific Co.
510(k) numberK862141
Submission
- Device name
- Histology Paraffin
- Applicant
- Erie Scientific Co.
Portsmouth, NH, US - Received
- June 4, 1986
- Decision date
- June 13, 1986
- 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 |
| 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 |
| K810568 | Paraffin Embedding MediumKEO · Traditional | Surgipath Medical Industries, Inc. | 03/17/1981SE |
| 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 |
Questions and answers
When was Histology Paraffin cleared by the FDA?
Histology Paraffin (K862141) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 9 days after the submission was received.
What is the product code of K862141?
The FDA product code is KEO – Formulations, Paraffin, All, a Class I (low risk) device regulated under 21 CFR 864.4010.