Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
The Radioimmunoassay for Digoxin using tritium (3-H) with goat antibody and second antibody separation is a laboratory test system that measures digoxin in patient serum using a double-antibody precipitation separation radioimmunoassay with tritium label and goat-derived primary antibodies. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DOY, regulated under 21 CFR 862.3320, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DOY
- Device Class
- FDA class 2
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K910154 | USCI ILLUMEN-8 8F PTCA GUIDING CATHETER | Apr 09, 1991 | Substantially Equivalent | C.R. Bard, Inc. |
| K832396 | CENTRAL VENOUS ACCESS CATHETER CVAC | Aug 31, 1983 | Substantially Equivalent | Gish Biomedical, Inc. |
| K831239 | WALRUS PERCUTANEOUS INTRODUCER SET | May 25, 1983 | Substantially Equivalent | Medical Parameters, Inc. |
| K831191 | VASCULAR CATHETER | May 09, 1983 | Substantially Equivalent | Medrad, Inc. |
| K831188 | CONNECTOR TUBE | May 09, 1983 | Substantially Equivalent | Medrad, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.