DON — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. Class II
FDA product code DON covers "Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 17 recent 510(k) clearances have been granted under this product code.
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 |