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510(k) K792584

Device
ACA ETHOSURIMIDE TEST PACK
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K792584
Product code
DLF  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-31
Date received
1979-12-14
Regulation
862.3380
Classification name
Enzyme Immunoassay, Ethosuximide
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DLF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881607EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647Em Diagnostic Systems, Inc.1988-06-01
K850174TDX ETHOSUXIMIDEAbbott Laboratories1985-02-06
K844204EMIT QST ETHOSUXIMIDE ASSAYSyva Co.1984-12-11
K832797MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSyva Co.1983-09-29
K823801AMES TDA ETHOSUXIMIDE TESTMiles Laboratories, Inc.1983-01-14
K823745ADVANCE EMIT-AED ETHOSUXIMIDESyva Co.1983-01-07
K780380ANALYZER, FAST, CENTRIFUGAL, GEMSAECSyva Co.1978-04-12
K780461ANALYZER-SUPPLEMENT, KINETIC, LKB 2086Syva Co.1978-04-12

Legacy Summary#

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FDA Review#

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