FDA product code · Clinical toxicology

Enzymatic Radiochemical Assay, Amikacin

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

LDNClass II21 CFR 862.3035510(k) required3 decisions since 19820 recalls

3 FDA decisions since 1982. 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 LDN 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.

FDA decisions per year · LDN

FDA has decided no LDN device since 2007.

Median 510(k) review, days · LDN

Too few LDN 510(k)s in any year since 2007 to give a median.

Recalls per year · LDN

No recall names LDN since 2007.

Adverse event reports per year · LDN

No MAUDE report names LDN since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in LDN? 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 862.3035.

KLQ Radioimmunoassay, Amikacin KLP Amikacin Serum Assay LGJ Fluorescence Polarization Immunoassay, Amibacin

Enzymatic Radiochemical Assay, Amikacin

What has FDA decided in LDN lately?

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