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DLF — Enzyme Immunoassay, Ethosuximide Class II

FDA Device Classification

Classification Details

Product Code
DLF
Device Class
Class II
Regulation Number
862.3380
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K881607em diagnostic systemsEASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647June 1, 1988
K850174abbott laboratoriesTDX ETHOSUXIMIDEFebruary 6, 1985
K844204syvaEMIT QST ETHOSUXIMIDE ASSAYDecember 11, 1984
K832797syvaMODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSeptember 29, 1983
K823801miles laboratoriesAMES TDA ETHOSUXIMIDE TESTJanuary 14, 1983
K823745syvaADVANCE EMIT-AED ETHOSUXIMIDEJanuary 7, 1983
K792584e.i. dupont de nemours and coACA ETHOSURIMIDE TEST PACKDecember 31, 1979
K780461syvaANALYZER-SUPPLEMENT, KINETIC, LKB 2086April 12, 1978
K780380syvaANALYZER, FAST, CENTRIFUGAL, GEMSAECApril 12, 1978