Decalcifier II
FDA 510(k) K810836 · Surgipath
510(k) numberK810836
Submission
- Device name
- Decalcifier II
- Applicant
- Surgipath
Mchenry, IL, US - Received
- March 26, 1981
- Decision date
- April 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872625 | Decalcifying SolutionKDX · Traditional | Stephens Scientific | 08/06/1987SE |
| K850636 | Simutaneous Fixation & Decalcifying Solution Cal-EKDX · Traditional | Fisher Scientific Co., LLC | 03/20/1985SE |
| K842726 | Decalcifier SolutionKDX · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K841488 | Decalcifier IKDX · Traditional | Surgipath Medical Industries, Inc. | 05/02/1984SE |
| K822036 | Volu-Sol DecalciferKDX · Traditional | Volu Sol Medical Industries | 08/03/1982SE |
| K821443 | FormicalKDX · Traditional | Lerner Laboratories, Inc. | 06/02/1982SE |
| K811801 | Cal-RiteKDX · Traditional | Richard-Allan Medical Ind., Inc. | 07/28/1981SE |
More from Richard-Allan Medical Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820027 | Modified Ea 50HZJ · Traditional | 02/04/1982SE |
| K812940 | 10% Neutral Buffered Formalin ConcentIFP · Traditional | 12/10/1981SE |
| K812087 | Ea 50HZJ · Traditional | 08/13/1981SE |
| K812086 | Ea 65HZJ · Traditional | 08/13/1981SE |
| K811826 | Eosin YHYB · Traditional | 07/10/1981SE |
| K811825 | Orange G-6HZH · Traditional | 07/10/1981SE |
| K810760 | Gill's Hematoxylin #3 · Traditional | 04/14/1981SE |
| K810759 | Gill's Hematoxylin #2HYJ · Traditional | 04/14/1981SE |
| K810758 | Gill's Hematoxylin #1HYJ · Traditional | 04/14/1981SE |
| K810733 | Harris HematoxylinHYK · Traditional | 04/14/1981SE |
Questions and answers
When was Decalcifier II cleared by the FDA?
Decalcifier II (K810836) received a 510(k) decision of Substantially Equivalent on April 23, 1981, 28 days after the submission was received.
What is the product code of K810836?
The FDA product code is KDX – Solution, Decalcifier, Acid Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.