DNL — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. Class II
FDA Device Classification
Classification Details
- Product Code
- DNL
- 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 |
|---|
| K852343 | m nobird | DIG RADIOIMMUNOASSAY TEST SYSTEM | July 9, 1985 |
| K852291 | nuclear diagnostics | TIPSEP DIGOXIN RIA | June 25, 1985 |
| K811212 | immuno assay | DIGOXIN (RIA) KIT | May 21, 1981 |
| K810966 | e. r. squibb and sons | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | April 21, 1981 |
| K802841 | american diagnostic | DIGOXIN RADIOIMMUNOASSAY KIT | December 18, 1980 |
| K781834 | wien laboratories | TEST SET, 125 I-DIGOXIN | January 3, 1979 |
| K781495 | new england nuclear | RIANEN ASSAY SYSTEM, 125I KIT | September 14, 1978 |
| K772110 | clinical assays | IN VITRO DIGOXIN RIA TEST | November 22, 1977 |