DLF · Class II · 21 CFR 862.3380

FDA Product Code DLF: Enzyme Immunoassay, Ethosuximide

Leading manufacturers include Syva Co., E.I. Dupont DE Nemours & Co., Inc. and Miles Laboratories, Inc..

9
Total
9
Cleared
31d
Avg days
1978
Since

FDA 510(k) Cleared Enzyme Immunoassay, Ethosuximide Devices (Product Code DLF)

9 devices
1–9 of 9
Cleared Jun 01, 1988
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
K881607
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Feb 06, 1985
TDX ETHOSUXIMIDE
K850174
Abbott Laboratories
Toxicology · 20d
Cleared Dec 11, 1984
EMIT QST ETHOSUXIMIDE ASSAY
K844204
Syva Co.
Toxicology · 42d
Cleared Sep 29, 1983
MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY
K832797
Syva Co.
Toxicology · 42d
Cleared Jan 14, 1983
AMES TDA ETHOSUXIMIDE TEST
K823801
Miles Laboratories, Inc.
Chemistry · 28d
Cleared Jan 07, 1983
ADVANCE EMIT-AED ETHOSUXIMIDE
K823745
Syva Co.
Chemistry · 25d
Cleared Dec 31, 1979
ACA ETHOSURIMIDE TEST PACK
K792584
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 17d
Cleared Apr 12, 1978
ANALYZER, FAST, CENTRIFUGAL, GEMSAEC
K780380
Syva Co.
Toxicology · 33d
Cleared Apr 12, 1978
ANALYZER-SUPPLEMENT, KINETIC, LKB 2086
K780461
Syva Co.
Toxicology · 20d

About Product Code DLF - Regulatory Context