Panels › Clinical Toxicology › Product code DON · Class 2
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Regulation 862.3320
0510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DON
| Company | 510(k)s | Recalls |
|---|---|---|
| Burroughs Wellcome Co. | 2 | 0 |
| Ciba Corning Diagnostics Corp. | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Biological & Diagnostic Products | 1 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Damon Corp. | 1 | 0 |
| E. R. Squibb & Sons, Inc. | 1 | 0 |
| Icl Scientific | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 1990 | K902861 | CIBA CORNING ACS DIGOXIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | DON |
| Jul 8, 1988 | K881679 | CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | DON |
| Mar 23, 1984 | K840461 | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY Corning Medical & Scientific | DON |
| Apr 5, 1983 | K830533 | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. | DON |
| Jul 27, 1982 | K822053 | ZETAPHASE-DIG Biological & Diagnostic Products | DON |
| Apr 26, 1982 | K821000 | ENZYMUNE-TEST DIGOXIN Icl Scientific | DON |
| Feb 19, 1981 | K810296 | DIGOXIN RIA ASSAY Ria Diagnostics | DON |
| Dec 22, 1980 | K803075 | DIGOXIN RIABEAD DIAGNOSTIC KIT Abbott Laboratories | DON |
| Sep 27, 1979 | K791549 | TECHNICON STAR SYSTEM Technicon Instruments Corp. | DON |
| Oct 24, 1978 | K781660 | RIA, DIGOXIN E. R. Squibb & Sons, Inc. | DON |
| Apr 24, 1978 | K780475 | DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT Burroughs Wellcome Co. | DON |
| Feb 23, 1978 | K780207 | LIQUISOL DIGOXIN RIA TEST KIT Damon Corp. | DON |
| Feb 13, 1978 | K772422 | QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA Bio-Rad | DON |
| Dec 20, 1977 | K772098 | DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS Bd Becton Dickinson Vacutainer Systems Preanalytic | DON |
| Aug 25, 1977 | K771255 | CEBTRIA DIGOXIN RIA Union Carbide Corp. | DON |
| Mar 16, 1977 | K770269 | CAMMADISK DIGOXIN Burroughs Wellcome Co. | DON |
| Nov 1, 1976 | K760800 | SPAC DIGOXIN KIT Mallinckrodt Critical Care | DON |
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