LFN
5 FDA 510(k) clearances · Product code
31 daysmedian time to decision
169 days90th percentile
5clearances measured
FDA profile
- Official device name
- Nephelometric Inhibition Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- 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 |
|---|---|---|
| QMS PHENOBARBITAL (K934388) | Seradyn, Inc. | 1994-02-25 |
| DART PHENOBARBITAL ASSAY SYSTEM (K864612) | Coulter Electronics, Inc. | 1987-01-13 |
| DUPONT PHENOBARBITAL ASSAY (K860304) | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| DUPONT PHENOBARBITAL CALIBRATOR (K860303) | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| IPA FOR DETECTION OF PHENOBARBITAL (K821543) | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 |
Track LFN automatically
Every clearance here is in the API, with alerts when new ones post.