510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DLFClass II

Enzyme Immunoassay, Ethosuximide

21 CFR 862.3380 / Clinical Toxicology
FDA source (opens on fda.gov)

DLF is the FDA product code for Enzyme Immunoassay, Ethosuximide, a class II device type, regulated under 21 CFR 862.3380. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DLF
Device name
Enzyme Immunoassay, Ethosuximide
Regulation
21 CFR 862.3380
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code DLF

By decision year
9 clearances under product code DLF with a decision year between 1978 and 1988, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DLF by decision year
YearClearances
19782
19791
19833
19841
19851
19881

Applicants with the most clearances

Product code DLF
Applicants holding the most 510(k) clearances under product code DLF
ApplicantClearances
Syva Co.4
Abbott Medical1
E.I. Dupont de Nemours & Co., Inc.1
Em Diagnostic Systems, Inc.1
Miles Laboratories, Inc.1
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code