DPO — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. Class II
FDA product code DPO covers "Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DPO
- 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 |
|---|---|---|---|
| K914833 | cirrus diagnostics | IMMULITE DIGOXIN | November 22, 1991 |
| K905719 | biotope | ECLIPSE ICA DIGOXIN | January 17, 1991 |
| K864449 | canadian bioclinical | DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | February 2, 1987 |
| K833842 | immuno assay | RIA COAT DIGOXIN | January 17, 1984 |
| K832163 | diagnostic products | SOPHEIA DIGOXIN EIA KIT | August 12, 1983 |
| K830962 | immuchem | IMMUCHEM COVALENT-COAT RIA KIT | May 4, 1983 |
| K811932 | diagnostic products | COAT-A-COUNT DIGOXIN RIA | July 23, 1981 |
| K811776 | kallestad laboratories | KALLESTAD QUANTICOAT 125 DIGOXIN | July 10, 1981 |
| K800205 | boehringer mannheim | RIA PHASE DIGOXIN | March 19, 1980 |
| K791325 | micromedic systems | AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM | August 16, 1979 |
| K791355 | ventrex laboratories | VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT | August 10, 1979 |
| K771638 | bd becton dickinson vacutainer systems preanalytic | IGOXIN SOLID PHASE RIA | October 7, 1977 |
| K770365 | travenol laboratories | RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO | February 24, 1977 |
| K770069 | e. r. squibb and sons | DIGOXIN CLASP TM RIA KIT | January 18, 1977 |