DLP
5 FDA 510(k) clearances · Product code
22 daysmedian time to decision
67 days90th percentile
5clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- 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 |
|---|---|---|
| FPR PHENYTOIN KIT (K894527) | Colony Laboratories, Inc. | 1989-09-25 |
| KALLESTAD ANTISERA TO PHENYTOIN (K811775) | Kallestad Laboratories, Inc. | 1981-07-10 |
| FLUOROMATIC PHENYTOIN FIA (K792640) | Bio-Rad | 1980-01-11 |
| CENTRIA PHENYTOIN RIA TEST SET (K791896) | Ventrex Laboratories, Inc. | 1979-10-17 |
| PHENYTOIN RIA KIT (K770779) | Amersham Corp. | 1977-06-17 |
Track DLP automatically
Every clearance here is in the API, with alerts when new ones post.