DOY
5 FDA 510(k) clearances · Product code
40 daysmedian time to decision
85 days90th percentile
5clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- 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 |
|---|---|---|
| USCI ILLUMEN-8 8F PTCA GUIDING CATHETER (K910154) | C.R. Bard, Inc. | 1991-04-09 |
| CENTRAL VENOUS ACCESS CATHETER CVAC (K832396) | Gish Biomedical, Inc. | 1983-08-31 |
| WALRUS PERCUTANEOUS INTRODUCER SET (K831239) | Medical Parameters, Inc. | 1983-05-25 |
| VASCULAR CATHETER (K831191) | Medrad, Inc. | 1983-05-09 |
| CONNECTOR TUBE (K831188) | Medrad, Inc. | 1983-05-09 |
Track DOY automatically
Every clearance here is in the API, with alerts when new ones post.