Digoxin Radioimmunoassay System
FDA 510(k) K792153 · Radioimmunoassay, Inc.
510(k) numberK792153
Submission
- Device name
- Digoxin Radioimmunoassay System
- Applicant
- Radioimmunoassay, Inc.
Mchenry, IL, US - Received
- October 26, 1979
- Decision date
- November 13, 1979
- 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 |
| K820274 | Digoxin RadioimmunoassayDPB · Traditional | American Diagnostic Corp. | 02/23/1982SE |
| 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 |
More from Nuclear Medical Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802135 | Testosterone Radioimmunoassy KitCDZ · Traditional | 10/10/1980SE |
| K800107 | Follicle Stimulating HormoneCGJ · Traditional | 02/13/1980SE |
| K800106 | Luteinizing Hormone Radioimmunoassay SysCEP · Traditional | 02/13/1980SE |
| K792539 | Triiodothyronine Ria SystemCDP · Traditional | 01/16/1980SE |
| K792154 | Thyroid Stimulating HormoneJLW · Traditional | 11/13/1979SE |
| K792036 | Cortisol Radioimmunoassay SystemCGR · Traditional | 10/30/1979SE |
| K780672 | 125 I-T4 Ria ReagentCDX · Traditional | 06/06/1978SE |
| K780671 | 125 I-T3 Uptake ReagentCEE · Traditional | 06/06/1978SE |
Questions and answers
When was Digoxin Radioimmunoassay System cleared by the FDA?
Digoxin Radioimmunoassay System (K792153) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 18 days after the submission was received.
What is the product code of K792153?
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.