LES
7 FDA 510(k) clearances · Product code
20 daysmedian time to decision
38 days90th percentile
7clearances measured
FDA profile
- Official device name
- Fluorescent 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 |
|---|---|---|
| IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS (K865102) | Sclavo, Inc. | 1987-01-13 |
| SYVA ADVANCE EMIT PHENYTOIN ASSAY (K844990) | Syva Co. | 1985-01-23 |
| STRATUS PHENYTOIN FLUOROMETRIC ENZYME (K831154) | American Dade | 1983-05-16 |
| SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY (K820187) | Syva Co. | 1982-02-12 |
| PHENYTOIN FLUORESCENT IMMUNOASSAY (K813538) | American Diagnostic Corp. | 1981-12-31 |
| AMES TDA TM PHENYTOIN TEST (K811025) | Miles Laboratories, Inc. | 1981-04-29 |
| AMES TDA TM PHENYTOIN TEST (K801736) | Miles Laboratories, Inc. | 1980-08-20 |
Track LES automatically
Every clearance here is in the API, with alerts when new ones post.