Dart Digoxin Assay
FDA 510(k) K864802 · Coulter Electronics, Inc.
510(k) numberK864802
Submission
- Device name
- Dart Digoxin Assay
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- December 9, 1986
- Decision date
- February 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCS – Radioimmunoassay, Digoxin (125-I)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922353 | Digoxin Coated Tube RiaLCS · Traditional | Monobind | 08/24/1992SE |
| K913562 | QMS - DigoxinLCS · Traditional | Seradyn, Inc. | 08/30/1991SE |
| K895828 | Innofluor Digoxin Reagent SetLCS · Traditional | Innotron of Oregon, Inc. | 10/30/1989SE |
| K884707 | Fiagen Digoxin Time-Resolved Fluoroimmunoassay KitLCS · Traditional | Cyberfluor, Inc. | 01/17/1989SE |
| K874748 | Immpulse Digoxin Assay ReagentsLCS · Traditional | Sclavo, Inc. | 02/19/1988SE |
| K820154 | TDX DigoxinLCS · Traditional | Abbott Laboratories | 02/05/1982SE |
| K812749 | Ultra-DigLCS · Traditional | Antibodies, Inc. | 10/19/1981SE |
| K803047 | I-125 Labeled DigoxinLCS · Traditional | Pcl-Ria, Inc. | 12/22/1980SE |
| K801490 | Digoxin Eia KitLCS · Traditional | M.A. Bioproducts | 07/14/1980SE |
| K801413 | Amerlex Digoxin Ria KitLCS · Traditional | Amersham Corp. | 07/08/1980SE |
More from Amersham Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K923951 | CD8 Cytospheres KitMAM · Traditional | 04/25/1994SE |
| K930119 | Coulter Retic-C Cell ControlJPK · Traditional | 04/05/1993SE |
| K921279 | CD4 Cytospheres KitGKZ · Traditional | 12/29/1992SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
| K922704 | Coulter Maxm W/ AutoloaderGKZ · Traditional | 07/27/1992SE |
| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
Questions and answers
When was Dart Digoxin Assay cleared by the FDA?
Dart Digoxin Assay (K864802) received a 510(k) decision of Substantially Equivalent on February 12, 1987, 65 days after the submission was received.
What is the product code of K864802?
The FDA product code is LCS – Radioimmunoassay, Digoxin (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3320.