DLF
9 FDA 510(k) clearances · Product code
28 daysmedian time to decision
50 days90th percentile
9clearances measured
FDA profile
- Official device name
- Enzyme Immunoassay, Ethosuximide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3380
- 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 |
|---|---|---|
| EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 (K881607) | Em Diagnostic Systems, Inc. | 1988-06-01 |
| TDX ETHOSUXIMIDE (K850174) | Abbott Laboratories | 1985-02-06 |
| EMIT QST ETHOSUXIMIDE ASSAY (K844204) | Syva Co. | 1984-12-11 |
| MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY (K832797) | Syva Co. | 1983-09-29 |
| AMES TDA ETHOSUXIMIDE TEST (K823801) | Miles Laboratories, Inc. | 1983-01-14 |
| ADVANCE EMIT-AED ETHOSUXIMIDE (K823745) | Syva Co. | 1983-01-07 |
| ACA ETHOSURIMIDE TEST PACK (K792584) | E.I. Dupont DE Nemours & Co., Inc. | 1979-12-31 |
| ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (K780461) | Syva Co. | 1978-04-12 |
| ANALYZER, FAST, CENTRIFUGAL, GEMSAEC (K780380) | Syva Co. | 1978-04-12 |
Track DLF automatically
Every clearance here is in the API, with alerts when new ones post.