LCS
15 FDA 510(k) clearances · Product code
22 daysmedian time to decision
93 days90th percentile
15clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Digoxin (125-I)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIGOXIN COATED TUBE RIA (K922353) | Monobind | 1992-08-24 |
| QMS - DIGOXIN (K913562) | Seradyn, Inc. | 1991-08-30 |
| INNOFLUOR DIGOXIN REAGENT SET (K895828) | Innotron of Oregon, Inc. | 1989-10-30 |
| FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884707) | Cyberfluor, Inc. | 1989-01-17 |
| IMMPULSE DIGOXIN ASSAY REAGENTS (K874748) | Sclavo, Inc. | 1988-02-19 |
| DART DIGOXIN ASSAY (K864802) | Coulter Electronics, Inc. | 1987-02-12 |
| TDX DIGOXIN (K820154) | Abbott Laboratories | 1982-02-05 |
| ULTRA-DIG (K812749) | Antibodies, Inc. | 1981-10-19 |
| I-125 LABELED DIGOXIN (K803047) | Pcl-Ria, Inc. | 1980-12-22 |
| DIGOXIN EIA KIT (K801490) | M.A. Bioproducts | 1980-07-14 |
| AMERLEX DIGOXIN RIA KIT (K801413) | Amersham Corp. | 1980-07-08 |
| DIGOXIN RADIOIMMUNOASSAY KIT (K801202) | Technia Diagnostics , Ltd. | 1980-06-20 |
| DIGOXIN CLASP RIA KIT (K800997) | E. R. Squibb & Sons, Inc. | 1980-05-08 |
| DIGOCTK 125 (K800773) | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-24 |
| PHALDEBAS DIGOXIN RIA (K770322) | Pharmacia, Inc. | 1977-04-05 |
Track LCS automatically
Every clearance here is in the API, with alerts when new ones post.