510(k) Report

FDA product code · Clinical toxicology

Hemagglutination, Opiates

DLTClass II21 CFR 862.3650510(k) required1 decision since 19790 recalls

1 FDA decision since 1979. 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 DLT 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 · DLT

FDA has decided no DLT device since 2007.

Median 510(k) review, days · DLT

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

Recalls per year · DLT

No recall names DLT since 2007.

Adverse event reports per year · DLT

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

Planning a device in DLT? 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 DLT lately?

  • K790400Urine Negative CalibratorSyva Co. · 1979

The one DLT decision →

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