LCS — Radioimmunoassay, Digoxin (125-I) Class II
FDA Device Classification
Classification Details
- Product Code
- LCS
- 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 |
|---|
| K922353 | monobind | DIGOXIN COATED TUBE RIA | August 24, 1992 |
| K913562 | seradyn | QMS - DIGOXIN | August 30, 1991 |
| K895828 | innotron of oregon | INNOFLUOR DIGOXIN REAGENT SET | October 30, 1989 |
| K884707 | cyberfluor | FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT | January 17, 1989 |
| K874748 | sclavo | IMMPULSE DIGOXIN ASSAY REAGENTS | February 19, 1988 |
| K864802 | coulter electronics | DART DIGOXIN ASSAY | February 12, 1987 |
| K820154 | abbott laboratories | TDX DIGOXIN | February 5, 1982 |
| K812749 | antibodies | ULTRA-DIG | October 19, 1981 |
| K803047 | pcl-ria | I-125 LABELED DIGOXIN | December 22, 1980 |
| K801490 | m.a. bioproducts | DIGOXIN EIA KIT | July 14, 1980 |
| K801413 | amersham | AMERLEX DIGOXIN RIA KIT | July 8, 1980 |
| K801202 | technia diagnostics | DIGOXIN RADIOIMMUNOASSAY KIT | June 20, 1980 |
| K800997 | e. r. squibb and sons | DIGOXIN CLASP RIA KIT | May 8, 1980 |
| K800773 | sorin biomedica, fiat, usa | DIGOCTK 125 | April 24, 1980 |
| K770322 | pharmacia | PHALDEBAS DIGOXIN RIA | April 5, 1977 |