Enzyme Immunoassay, Ethosuximide
The Enzyme Immunoassay for Ethosuximide is a laboratory test system that employs enzyme immunoassay methodology to measure ethosuximide, an anticonvulsant drug used to treat absence seizures, in patient serum or plasma. It is a Class 2 device requiring 510(k) premarket notification. The product code is DLF, regulated under 21 CFR 862.3380, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DLF
- Device Class
- FDA class 2
- Regulation Number
- 862.3380
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881607 | EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 | Jun 01, 1988 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K850174 | TDX ETHOSUXIMIDE | Feb 06, 1985 | Substantially Equivalent | Abbott Laboratories |
| K844204 | EMIT QST ETHOSUXIMIDE ASSAY | Dec 11, 1984 | Substantially Equivalent | Syva Co. |
| K832797 | MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY | Sep 29, 1983 | Substantially Equivalent | Syva Co. |
| K823801 | AMES TDA ETHOSUXIMIDE TEST | Jan 14, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K823745 | ADVANCE EMIT-AED ETHOSUXIMIDE | Jan 07, 1983 | Substantially Equivalent | Syva Co. |
| K792584 | ACA ETHOSURIMIDE TEST PACK | Dec 31, 1979 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K780461 | ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 | Apr 12, 1978 | Substantially Equivalent | Syva Co. |
| K780380 | ANALYZER, FAST, CENTRIFUGAL, GEMSAEC | Apr 12, 1978 | Substantially Equivalent | Syva Co. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.