Vaspar Sealent
FDA 510(k) K812191 · American Scientific Products
510(k) numberK812191
Submission
- Device name
- Vaspar Sealent
- Applicant
- American Scientific Products
Walker, MI, US - Received
- August 3, 1981
- Decision date
- August 31, 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 |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864824 | Infectious Tissue Kit · Traditional | 12/24/1986SE |
| K844042 | Blood Dilution VialGKL · Traditional | 10/23/1984SE |
| K831634 | Glucose Reagent B6360-11CGA · Traditional | 07/19/1983SE |
| K831626 | Urea Nitrogen-Bun-Reagents B6370-11ACDQ · Traditional | 07/07/1983SE |
| K831625 | Urea Nitrogen-Bun-Reagents B6360-12CDQ · Traditional | 07/07/1983SE |
| K831628 | Creatinine Reagents B6370-13CGX · Traditional | 07/06/1983SE |
| K831627 | Creatinine Reagents B6360-10CGX · Traditional | 07/06/1983SE |
| K831624 | Glucose Reagent KITS-B6370-10ACGA · Traditional | 07/06/1983SE |
| K831571 | RotorJJG · Traditional | 06/30/1983SE |
| K831569 | Reagent CupsJJG · Traditional | 06/30/1983SE |
Questions and answers
When was Vaspar Sealent cleared by the FDA?
Vaspar Sealent (K812191) received a 510(k) decision of Substantially Equivalent on August 31, 1981, 28 days after the submission was received.
What is the product code of K812191?
The FDA product code is KEO – Formulations, Paraffin, All, a Class I (low risk) device regulated under 21 CFR 864.4010.