LFO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Nephelometric Inhibition Immunoassay, 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 |
|---|---|---|
| DART PHENYTOIN (K880294) | Coulter Electronics, Inc. | 1988-05-27 |
Track LFO automatically
Every clearance here is in the API, with alerts when new ones post.