Digoxin Radioimmunoassay
FDA 510(k) K820274 · American Diagnostic Corp.
510(k) numberK820274
Submission
- Device name
- Digoxin Radioimmunoassay
- Applicant
- American Diagnostic Corp.
Mchenry, IL, US - Received
- February 2, 1982
- Decision date
- February 23, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPB – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DPB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K853021 | Optimate Digoxin TestDPB · Traditional | Miles Laboratories, Inc. | 08/07/1985SE |
| K823014 | Digoxin KitDPB · Traditional | Pcl-Ria, Inc. | 11/01/1982SE |
| K821811 | 125I Digoxin Radioimmunoassay KitDPB · Traditional | Cambridge Medical Technology | 07/02/1982SE |
| K792153 | Digoxin Radioimmunoassay SystemDPB · Traditional | Radioimmunoassay, Inc. | 11/13/1979SE |
| K790602 | Ria, DIGNXIN-125-IDPB · Traditional | Endocrine-Metabolic Center | 07/30/1979SE |
| K790540 | Ria Test Kit, Centria DigoxinDPB · Traditional | Ventrex Laboratories, Inc. | 04/23/1979SE |
| K772306 | 125I Digoxin Test SetDPB · Traditional | Wien Laboratories, Inc. | 12/22/1977SE |
| K771525 | 125 I Digoxin Ria KitDPB · Traditional | Diagnostic Products Corp. | 10/14/1977SE |
| K760883 | Digi-Tab-Ria Digoxin RadiommunoassayDPB · Traditional | Nuclear Medical Laboratories, Inc. | 11/19/1976SE |
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Questions and answers
When was Digoxin Radioimmunoassay cleared by the FDA?
Digoxin Radioimmunoassay (K820274) received a 510(k) decision of Substantially Equivalent on February 23, 1982, 21 days after the submission was received.
What is the product code of K820274?
The FDA product code is DPB – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.