Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
The Radioimmunoassay for Digoxin using iodine-125 with rabbit antibody and solid phase separation is a laboratory test system that quantifies digoxin in patient serum using a solid-phase bound radioimmunoassay format, important for monitoring therapeutic levels of this narrow therapeutic index cardiac drug. It is a Class 2 device requiring 510(k) premarket notification. The product code is DON, regulated under 21 CFR 862.3320, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
Research product code DON in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DON
- Device Class
- FDA class 2
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K902861 | CIBA CORNING ACS DIGOXIN IMMUNOASSAY | Sep 10, 1990 | Substantially Equivalent | Ciba Corning Diagnostics Corp. |
| K881679 | CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY | Jul 08, 1988 | Substantially Equivalent | Ciba Corning Diagnostics Corp. |
| K840461 | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY | Mar 23, 1984 | Substantially Equivalent | Corning Medical & Scientific |
| K830533 | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT | Apr 05, 1983 | Substantially Equivalent | Medical & Scientific Designs, Inc. |
| K822053 | ZETAPHASE-DIG | Jul 27, 1982 | Substantially Equivalent | Biological & Diagnostic Products |
| K821000 | ENZYMUNE-TEST DIGOXIN | Apr 26, 1982 | Substantially Equivalent | Icl Scientific |
| K810296 | DIGOXIN RIA ASSAY | Feb 19, 1981 | Substantially Equivalent | Ria Diagnostics |
| K803075 | DIGOXIN RIABEAD DIAGNOSTIC KIT | Dec 22, 1980 | Substantially Equivalent | Abbott Laboratories |
| K791549 | TECHNICON STAR SYSTEM | Sep 27, 1979 | Substantially Equivalent | Technicon Instruments Corp. |
| K781660 | RIA, DIGOXIN | Oct 24, 1978 | Substantially Equivalent | E. R. Squibb & Sons, Inc. |
| K780475 | DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT | Apr 24, 1978 | Substantially Equivalent | Burroughs Wellcome Co. |
| K780207 | LIQUISOL DIGOXIN RIA TEST KIT | Feb 23, 1978 | Substantially Equivalent | Damon Corp. |
| K772422 | QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA | Feb 13, 1978 | Substantially Equivalent | Bio-Rad |
| K772098 | DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS | Dec 20, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K771255 | CEBTRIA DIGOXIN RIA | Aug 25, 1977 | Substantially Equivalent | Union Carbide Corp. |
| K770269 | CAMMADISK DIGOXIN | Mar 16, 1977 | Substantially Equivalent | Burroughs Wellcome Co. |
| K760800 | SPAC DIGOXIN KIT | Nov 01, 1976 | Substantially Equivalent | Mallinckrodt Critical Care |