Decalcifier I
FDA 510(k) K841488 · Surgipath Medical Industries, Inc.
510(k) numberK841488
Submission
- Device name
- Decalcifier I
- Applicant
- Surgipath Medical Industries, Inc.
Mchenry, IL, US - Received
- April 10, 1984
- Decision date
- May 2, 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 |
| K842726 | Decalcifier SolutionKDX · Traditional | E K Ind., Inc. | 08/03/1984SE |
| 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 |
|---|---|---|
| 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 Decalcifier I cleared by the FDA?
Decalcifier I (K841488) received a 510(k) decision of Substantially Equivalent on May 2, 1984, 22 days after the submission was received.
What is the product code of K841488?
The FDA product code is KDX – Solution, Decalcifier, Acid Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.