LET
8 FDA 510(k) clearances · Product code
45 daysmedian time to decision
71 days90th percentile
8clearances measured
FDA profile
- Official device name
- Fluorescent 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 |
|---|---|---|
| MODIFIED OPUS PHENOBARBITAL TEST SYSTEM (K901537) | Pb Diagnostic Systems, Inc. | 1990-06-12 |
| IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS (K865000) | Sclavo, Inc. | 1987-02-06 |
| AMES TDA PHENOBARBITAL TEST (K842592) | Miles Laboratories, Inc. | 1984-08-17 |
| STRATUS PHENOBARBITAL FLUOROMETRIC ENZ (K830701) | American Dade | 1983-05-13 |
| PHENOBARBITAL FLUORESCENT IMMUNO (K821408) | American Diagnostic Corp. | 1982-05-24 |
| PHENOBARBITAL ASSAY (K820188) | Syva Co. | 1982-02-05 |
| AMES TDA TM PHENOBARBITAL TEST (K810994) | Miles Laboratories, Inc. | 1981-04-29 |
| AMES TDA PHENOBARBITAL TEST (K802255) | Miles Laboratories, Inc. | 1980-09-26 |
Track LET automatically
Every clearance here is in the API, with alerts when new ones post.