FDA product code · Immunology

Lactic Dehydrogenase, Antigen, Antiserum, Control

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

DETClass I21 CFR 866.5560510(k) exempt1 decision since 19900 recalls

FDA lists DET as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1990. 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 DET 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 · DET

FDA has decided no DET device since 2007.

Median 510(k) review, days · DET

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

Recalls per year · DET

No recall names DET since 2007.

Adverse event reports per year · DET

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

Planning a device in DET? 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

Lactic Dehydrogenase, Antigen, Antiserum, Control

What has FDA decided in DET lately?