Decalcifier Solution
FDA 510(k) K842726 · E K Ind., Inc.
510(k) numberK842726
Submission
- Device name
- Decalcifier Solution
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- August 3, 1984
- 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 |
| 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 |
| K810836 | Decalcifier IIKDX · Traditional | Surgipath | 04/23/1981SE |
More from Surgipath
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
Questions and answers
When was Decalcifier Solution cleared by the FDA?
Decalcifier Solution (K842726) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 21 days after the submission was received.
What is the product code of K842726?
The FDA product code is KDX – Solution, Decalcifier, Acid Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.