FDA.reportPublic FDA data

510(k) K881607

Device
Easy-test Emit(r) Ethosuximide (eths) Item 16647
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
510(k) number
K881607
Product code
DLF
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-01
Date received
1988-04-12
Regulation
862.3380
Classification name
Enzyme Immunoassay, Ethosuximide
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND L MILLER
Address
480 Democrat Rd. Gibbstown NJ US 08027 08027

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
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
K792584ACA ETHOSURIMIDE TEST PACKE.I. Dupont DE Nemours & Co., Inc.1979-12-31
K780380ANALYZER, FAST, CENTRIFUGAL, GEMSAECSyva Co.1978-04-12
K780461ANALYZER-SUPPLEMENT, KINETIC, LKB 2086Syva Co.1978-04-12