FDA product code · Clinical toxicology

Fluorescent Immunoassay, Phenobarbital

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

LETClass II21 CFR 862.3660510(k) required8 decisions since 19800 recalls

8 FDA decisions 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 LET 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 · LET

FDA has decided no LET device since 2007.

Median 510(k) review, days · LET

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

Recalls per year · LET

No recall names LET since 2007.

Adverse event reports per year · LET

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

Planning a device in LET? 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 862.3660.

DKP Radioimmunoassay, Phenobarbital DOO Liquid Chromatography, Phenobarbital LGQ Fluorescence Polarization Immunoassay…DLZ Enzyme Immunoassay, Phenobarbital LFN Nephelometric Inhibition Immunoassay…DIX Thin Layer Chromatography, Phenobarbital DJH Gas Chromatography, Phenobarbital LDA U.V. Spectrometry, Phenobarbital

Fluorescent Immunoassay, Phenobarbital

What has FDA decided in LET lately?

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