Digoxin Riabead Diagnostic Kit
FDA 510(k) K803075 · Abbott Laboratories
510(k) numberK803075
Submission
- Device name
- Digoxin Riabead Diagnostic Kit
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- December 5, 1980
- Decision date
- December 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DON – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K902861 | Ciba Corning Acs Digoxin ImmunoassayDON · Traditional | Ciba Corning Diagnostics Corp. | 09/10/1990SE |
| K881679 | Ciba Corning Magic Lite Digoxin ImmunoassayDON · Traditional | Ciba Corning Diagnostics Corp. | 07/08/1988SE |
| K840461 | Magic 125I Digoxin RadioimmunoassayDON · Traditional | Corning Medical & Scientific | 03/23/1984SE |
| K830533 | Phase II Digoxin Radioimmunoassay KitDON · Traditional | Medical & Scientific Designs, Inc. | 04/05/1983SE |
| K822053 | Zetaphase-DigDON · Traditional | Biological & Diagnostic Products | 07/27/1982SE |
| K821000 | Enzymune-Test DigoxinDON · Traditional | Icl Scientific | 04/26/1982SE |
| K810296 | Digoxin Ria AssayDON · Traditional | Ria Diagnostics | 02/19/1981SE |
| K791549 | Technicon Star SystemDON · Traditional | Technicon Instruments Corp. | 09/27/1979SE |
| K781660 | Ria, DigoxinDON · Traditional | E. R. Squibb & Sons, Inc. | 10/24/1978SE |
| K780475 | Dac-Cel Digoxin Radioimmunoassay KitDON · Traditional | Burroughs Wellcome Co. | 04/24/1978SE |
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Questions and answers
When was Digoxin Riabead Diagnostic Kit cleared by the FDA?
Digoxin Riabead Diagnostic Kit (K803075) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 17 days after the submission was received.
What is the product code of K803075?
The FDA product code is DON – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.