510(k) Report

FDA product code · Clinical toxicology

Thin Layer Chromatography, Theophylline

LEWClass II21 CFR 862.3880510(k) required1 decision since 19770 recalls

1 FDA decision since 1977. 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 LEW 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 · LEW

FDA has decided no LEW device since 2007.

Median 510(k) review, days · LEW

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

Recalls per year · LEW

No recall names LEW since 2007.

Adverse event reports per year · LEW

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

Planning a device in LEW? 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 LEW lately?

  • K771120Impreflex Alginate Impression MaterialEspe Dental Products · 1977

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Related product codes

Other codes under 21 CFR 862.3880.

LER Fluorescent Immunoassay, TheophyllineLCY U.V. Spectrometry, TheophyllineLCA Radioimmunoassay, TheophyllineLGS Fluorescence Polarization Immunoassay…KLS Enzyme Immunoassay, Theophylline