DKA — Antiserum, Digoxin Class II
FDA Device Classification
Classification Details
- Product Code
- DKA
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K934003 | baxter diagnostics | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY | November 22, 1994 |
| K780498 | clinical bioresearch | CBR-DIGOXIN ANTISERUM | April 5, 1978 |
| K780316 | pcl-ria | RABBIT ANTIBODY TO DIGOXIN | March 17, 1978 |