510(k) Report

FDA product code · Clinical toxicology

Thin Layer Chromatography, Opiates

LAIClass II21 CFR 862.3650510(k) required1 decision since 19930 recalls

1 FDA decision since 1993. 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 LAI 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 · LAI

FDA has decided no LAI device since 2007.

Median 510(k) review, days · LAI

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

Recalls per year · LAI

No recall names LAI since 2007.

Adverse event reports per year · LAI

No MAUDE report names LAI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — LAI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LAI? 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

What has FDA decided in LAI lately?

  • K932209Toxi*Lab LTD Opiate SystemToxi-Lab, Inc. · 1993

The one LAI decision →

Related product codes

Other codes under 21 CFR 862.3650.

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