Digi-Tab-Ria Digoxin Radiommunoassay
FDA 510(k) K760883 · Nuclear Medical Laboratories, Inc.
510(k) numberK760883
Submission
- Device name
- Digi-Tab-Ria Digoxin Radiommunoassay
- Applicant
- Nuclear Medical Laboratories, Inc.
Mchenry, IL, US - Received
- October 21, 1976
- Decision date
- November 19, 1976
- 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 |
| 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 |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K852438 | NML TSH IrmaJLW · Traditional | 07/12/1985SE |
| K844583 | Tsh-StatJLW · Traditional | 03/05/1985SE |
| K840466 | NML Cortisol RiaCGR · Traditional | 03/30/1984SE |
| K840589 | Tri-Tube RiaKHQ · Traditional | 03/09/1984SE |
| K832892 | Modified Chorio-ShureJHI · Traditional | 10/28/1983SE |
| K832002 | NML-5010/5020 Multi-Detector SystemJJJ · Traditional | 08/08/1983SE |
| K823679 | NML 6000 CTJQP · Traditional | 01/07/1983SE |
| K823053 | Nml-Tetra-Tube RiaCDX · Traditional | 11/10/1982SE |
| K822298 | Diagnostic Radioimmunoassay for QuantiJFH · Traditional | 09/02/1982SE |
| K820523 | Chorio-QuantJHI · Traditional | 03/15/1982SE |
Questions and answers
When was Digi-Tab-Ria Digoxin Radiommunoassay cleared by the FDA?
Digi-Tab-Ria Digoxin Radiommunoassay (K760883) received a 510(k) decision of Substantially Equivalent on November 19, 1976, 29 days after the submission was received.
What is the product code of K760883?
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.