FDA product code DLF: Enzyme Immunoassay, Ethosuximide
DLF is the FDA product code for enzyme immunoassay, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel. FDA has cleared 9 510(k) submissions under DLF, from 5 different applicants. The average 510(k) review took 31 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Ethosuximide |
| Device class | Class II |
| Regulation | 21 CFR 862.3380 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DLF clearance
Top DLF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 5 | 1984-12-11 |
| Em Diagnostic Systems, Inc. | 1 | 1988-06-01 |
| Abbott Laboratories | 1 | 1985-02-06 |
| Miles Laboratories, Inc. | 1 | 1983-01-14 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1979-12-31 |
Most recent DLF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881607 | Em Diagnostic Systems, Inc. | EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 | 1988-06-01 | 50 |
| K850174 | Abbott Laboratories | TDX ETHOSUXIMIDE | 1985-02-06 | 20 |
| K844204 | Syva Co. | EMIT QST ETHOSUXIMIDE ASSAY | 1984-12-11 | 42 |
| K832797 | Syva Co. | MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY | 1983-09-29 | 42 |
| K823801 | Miles Laboratories, Inc. | AMES TDA ETHOSUXIMIDE TEST | 1983-01-14 | 28 |
Recalls for DLF devices
openFDA lists no recalls for product code DLF.
Frequently asked questions
What is FDA product code DLF?
DLF is the FDA product code for enzyme immunoassay, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel.
What device class is DLF?
Class II, regulation 21 CFR 862.3380. Typical premarket route: 510(k).
How long does a 510(k) take for product code DLF?
Across 9 cleared submissions the average was 31 days from receipt to decision (median 28).
Which companies have the most DLF clearances?
Syva Co. (5); Em Diagnostic Systems, Inc. (1); Abbott Laboratories (1); Miles Laboratories, Inc. (1); E.I. Dupont DE Nemours & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLF
- Run a recall and safety report across every DLF manufacturer
- Watch product code DLF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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