FDA product code · Immunology

Igm, Rhodamine, Antigen, Antiserum, Control

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

DEZClass II21 CFR 866.5550510(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, immunology panel

Twenty years of DEZ 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 · DEZ

FDA has decided no DEZ device since 2007.

Median 510(k) review, days · DEZ

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

Recalls per year · DEZ

No recall names DEZ since 2007.

Adverse event reports per year · DEZ

2in 2025

2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code DEZ, not matched to any one device; reports are not rates.

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	—	2
2026	—	—

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

Planning a device in DEZ? 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 866.5550.