FDA product code · Clinical toxicology

Hemagglutination Inhibition, Methadone

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

DIWClass II21 CFR 862.3620510(k) required4 decisions since 19760 recalls

4 FDA decisions since 1976. 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 DIW 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 · DIW

FDA has decided no DIW device since 2007.

Median 510(k) review, days · DIW

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

Recalls per year · DIW

No recall names DIW since 2007.

Adverse event reports per year · DIW

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

Planning a device in DIW? 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 862.3620.

PVE Test, Methadone, Employment And Insurance…DMB Gas Chromatography, Methadone DNT Liquid Chromatography, Methadone DPP Free Radical Assay, Methadone DJR Enzyme Immunoassay, Methadone PTG Test, Methadone, Over The Counter DKR Thin Layer Chromatography, Methadone

Hemagglutination Inhibition, Methadone

What has FDA decided in DIW lately?

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