FDA product code · Clinical toxicology

Thin Layer Chromatography, Benzoylecgnonine

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

DOMClass II21 CFR 862.3250510(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 DOM 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 — DOM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DOM? 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

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Other codes under 21 CFR 862.3250.

LAC High Pressure Liquid Chromatography, Cocaine…NFY Test, Cocaine And Cocaine Metabolites, Over…DNG Free Radical, Benzoylecgnonine PVA Test, Cocaine And Cocaine Metabolite…DLN Hemagglutination, Cocaine Metabolites…KLN Radioimmunoassay, Cocaine Metabolite JXO Enzyme Immunoassay, Cocaine DMN Thin Layer Chromatography, Cocaine DIN Gas Chromatography, Cocaine DIR Free Radical Assay, Cocaine DIO Enzyme Immunoassay, Cocaine And Cocaine…