125I Digoxin Test Set
FDA 510(k) K772306 · Wien Laboratories, Inc.
510(k) numberK772306
Submission
- Device name
- 125I Digoxin Test Set
- Applicant
- Wien Laboratories, Inc.
Mchenry, IL, US - Received
- December 15, 1977
- Decision date
- December 22, 1977
- 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 |
| 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 |
| 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 |
|---|---|---|
| K912850 | SHBGCDZ · Traditional | 08/12/1991SE |
| K834246 | Progesterone Test Set 125I 17-OHJLX · Traditional | 02/04/1984SE |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | 09/12/1983SE |
| K823200 | 125 I-Dehydroepiandrosterone SulfateJKC · Traditional | 11/29/1982SE |
| K821653 | Protriptyline Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K821652 | Doxepin Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K802728 | 125I-TESTOSTERONE Test SetCDZ · Traditional | 12/11/1980SE |
| K792041 | Dhea-Sulfate Test SetJKC · Traditional | 10/30/1979SE |
| K781834 | Test Set, 125 I-DigoxinDNL · Traditional | 01/03/1979SE |
| K781599 | I-Estriol Test SetCGI · Traditional | 10/17/1978SE |
Questions and answers
When was 125I Digoxin Test Set cleared by the FDA?
125I Digoxin Test Set (K772306) received a 510(k) decision of Substantially Equivalent on December 22, 1977, 7 days after the submission was received.
What is the product code of K772306?
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.