LCS — Radioimmunoassay, Digoxin (125-I) Class II
FDA product code LCS covers "Radioimmunoassay, Digoxin (125-I)", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 15 recent 510(k) clearances have been granted under this product code.
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 |