DKH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gas Chromatography, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2009: 2 · 2010: 4 · 2012: 15 · 2013: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DUPONT PREP APPLI. FOR PHENOBARBITAL, (K801276) | E.I. Dupont DE Nemours & Co., Inc. | 1980-06-20 |
| ANTICONVULSANTS III CALIBRATOR KIT (K780733) | Vitek Systems, Inc. | 1978-06-22 |
Track DKH automatically
Every clearance here is in the API, with alerts when new ones post.