FDA product code · Clinical toxicology

Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.

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

DNJClass II21 CFR 862.3320510(k) required2 decisions since 19770 recalls

2 FDA decisions since 1977. 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 DNJ 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 · DNJ

FDA has decided no DNJ device since 2007.

Median 510(k) review, days · DNJ

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

Recalls per year · DNJ

No recall names DNJ since 2007.

Adverse event reports per year · DNJ

No MAUDE report names DNJ 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 — DNJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DNJ? 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 862.3320.

Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.

What has FDA decided in DNJ lately?

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