Product Code: DPB
FDA class 2
21 CFR 862.3320
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
Clinical Toxicology
The Radioimmunoassay for Digoxin using iodine-125 with rabbit antibody and charcoal separation is a laboratory test system that quantifies digoxin in patient serum using a charcoal adsorption separation radioimmunoassay format with iodine-125 tracer and rabbit-derived antibodies. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DPB, regulated under 21 CFR 862.3320, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
510(k)s
10
FEI Numbers
0
Registration Numbers
0
Unique Applicants
10
Years Active
9
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Basic Information
- Product Code
- DPB
- Device Class
- FDA class 2
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853021 | OPTIMATE DIGOXIN TEST | Aug 07, 1985 | Substantially Equivalent | Miles Laboratories, Inc. |
| K823014 | DIGOXIN KIT | Nov 01, 1982 | Substantially Equivalent | Pcl-Ria, Inc. |
| K821811 | 125I DIGOXIN RADIOIMMUNOASSAY KIT | Jul 02, 1982 | Substantially Equivalent | Cambridge Medical Technology |
| K820274 | DIGOXIN RADIOIMMUNOASSAY | Feb 23, 1982 | Substantially Equivalent | American Diagnostic Corp. |
| K792153 | DIGOXIN RADIOIMMUNOASSAY SYSTEM | Nov 13, 1979 | Substantially Equivalent | Radioimmunoassay, Inc. |
| K790602 | RIA, DIGNXIN-125-I | Jul 30, 1979 | Substantially Equivalent | Endocrine-Metabolic Center |
| K790540 | RIA TEST KIT, CENTRIA DIGOXIN | Apr 23, 1979 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K772306 | 125I DIGOXIN TEST SET | Dec 22, 1977 | Substantially Equivalent | Wien Laboratories, Inc. |
| K771525 | 125 I DIGOXIN RIA KIT | Oct 14, 1977 | Substantially Equivalent | Diagnostic Products Corp. |
| K760883 | DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY | Nov 19, 1976 | Substantially Equivalent | Nuclear Medical Laboratories, Inc. |