I-125 Labeled Digoxin
FDA 510(k) K803047 · Pcl-Ria, Inc.
510(k) numberK803047
Submission
- Device name
- I-125 Labeled Digoxin
- Applicant
- Pcl-Ria, Inc.
Mchenry, IL, US - Received
- December 1, 1980
- Decision date
- December 22, 1980
- 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 |
| K864802 | Dart Digoxin AssayLCS · Traditional | Coulter Electronics, Inc. | 02/12/1987SE |
| K820154 | TDX DigoxinLCS · Traditional | Abbott Laboratories | 02/05/1982SE |
| K812749 | Ultra-DigLCS · Traditional | Antibodies, Inc. | 10/19/1981SE |
| 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 |
|---|---|---|
| K830526 | B-Gcg System by RiaJHI · Traditional | 04/05/1983SE |
| K823014 | Digoxin KitDPB · Traditional | 11/01/1982SE |
| K822935 | Thyroid Stimulating HormoneJLW · Traditional | 11/01/1982SE |
| K822612 | T3 Uptake KitsKHQ · Traditional | 09/30/1982SE |
| K820886 | Thyroxine T4 KitCDX · Traditional | 04/16/1982SE |
| K820358 | Follicle Stimulating Hormone KitCGJ · Traditional | 03/26/1982SE |
| K820357 | Luteinizing Hormone KitCEP · Traditional | 03/25/1982SE |
| K812666 | Thyroxine (T4) 125ICDP · Traditional | 10/02/1981SE |
| K810867 | Follicle Stimulating Hormone (FSH)JIS · Traditional | 04/14/1981SE |
| K810852 | Follicle Stimulating Hormone AntiserumCGJ · Traditional | 04/08/1981SE |
Questions and answers
When was I-125 Labeled Digoxin cleared by the FDA?
I-125 Labeled Digoxin (K803047) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 21 days after the submission was received.
What is the product code of K803047?
The FDA product code is LCS – Radioimmunoassay, Digoxin (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3320.