FDA product code · Clinical toxicology

Gas Chromatography, Alcohol

Name: FDA decisions, review times, recalls and adverse event reports for product code DLH
Creator: 510(k) Report

DLHClass II21 CFR 862.3040510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical toxicology panel

Twenty years of DLH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — DLH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DLH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.3040.

ORA Breast Milk-Alcohol Test System DMJ Test Reagents For Ethyl Alcohol OIC Blood Alcohol Kit (Excludes Hiv Testing)DLS Gas Chromatograph, Alcohol (Dedicated…DOJ Potassium Dichromate, Alcohol DMT Enzymatic Method, Alcohol Dehydrogenase…DIC Alcohol Dehydrogenase, Specific Reagent For…DIZ Delayed Analysis, Alcohol DMI Potassium Dichromate Specific Reagent For…DLA Test Reagents For Methyl Alcohol DML Nad-Nadh, Specific Reagent For Alcohol Enzyme…