Product Code: DKA
FDA class 2
21 CFR 862.3320
Antiserum, Digoxin
Clinical Toxicology
The Digoxin Antiserum is an immunological reagent containing antibodies specific to digoxin, a cardiac glycoside used in the treatment of heart failure and atrial arrhythmias, enabling quantitative immunoassay measurement of digoxin in patient blood for therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3320 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
17
Basic Information
- Product Code
- DKA
- 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
Loading...
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934003 | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY | Nov 22, 1994 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K780498 | CBR-DIGOXIN ANTISERUM | Apr 05, 1978 | Substantially Equivalent | Clinical Bioresearch |
| K780316 | RABBIT ANTIBODY TO DIGOXIN | Mar 17, 1978 | Substantially Equivalent | Pcl-Ria, Inc. |