FDA product code · Clinical toxicology

Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.

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

DORClass II21 CFR 862.3320510(k) required1 decision since 19800 recalls

1 FDA decision since 1980. 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 DOR 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 · DOR

FDA has decided no DOR device since 2007.

Median 510(k) review, days · DOR

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

Recalls per year · DOR

No recall names DOR since 2007.

Adverse event reports per year · DOR

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

Planning a device in DOR? 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 (3-H), Bovine Antibody, Charcoal Sep.

What has FDA decided in DOR lately?

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