TDX Digoxin
FDA 510(k) K820154 · Abbott Laboratories
510(k) numberK820154
Submission
- Device name
- TDX Digoxin
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- January 19, 1982
- Decision date
- February 5, 1982
- 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 |
| 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 |
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Questions and answers
When was TDX Digoxin cleared by the FDA?
TDX Digoxin (K820154) received a 510(k) decision of Substantially Equivalent on February 5, 1982, 17 days after the submission was received.
What is the product code of K820154?
The FDA product code is LCS – Radioimmunoassay, Digoxin (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3320.