DON — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. Class II
FDA Device Classification
Classification Details
- Product Code
- DON
- 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 |
|---|
| K902861 | ciba corning diagnostics | CIBA CORNING ACS DIGOXIN IMMUNOASSAY | September 10, 1990 |
| K881679 | ciba corning diagnostics | CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY | July 8, 1988 |
| K840461 | corning medical and scientific | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY | March 23, 1984 |
| K830533 | medical and scientific designs | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT | April 5, 1983 |
| K822053 | biological and diagnostic products | ZETAPHASE-DIG | July 27, 1982 |
| K821000 | icl scientific | ENZYMUNE-TEST DIGOXIN | April 26, 1982 |
| K810296 | ria diagnostics | DIGOXIN RIA ASSAY | February 19, 1981 |
| K803075 | abbott laboratories | DIGOXIN RIABEAD DIAGNOSTIC KIT | December 22, 1980 |
| K791549 | technicon instruments | TECHNICON STAR SYSTEM | September 27, 1979 |
| K781660 | e. r. squibb and sons | RIA, DIGOXIN | October 24, 1978 |
| K780475 | burroughs wellcome | DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT | April 24, 1978 |
| K780207 | damon | LIQUISOL DIGOXIN RIA TEST KIT | February 23, 1978 |
| K772422 | bio-rad | QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA | February 13, 1978 |
| K772098 | bd becton dickinson vacutainer systems preanalytic | DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS | December 20, 1977 |
| K771255 | union carbide | CEBTRIA DIGOXIN RIA | August 25, 1977 |
| K770269 | burroughs wellcome | CAMMADISK DIGOXIN | March 16, 1977 |
| K760800 | mallinckrodt critical care | SPAC DIGOXIN KIT | November 1, 1976 |