510(k) Report

FDA product code · Clinical toxicology

Mercury Dithiazone, Colorimetry, Barbiturate

DJNClass II21 CFR 862.3150510(k) required1 decision since 19820 recalls

1 FDA decision since 1982. 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 DJN 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 · DJN

FDA has decided no DJN device since 2007.

Median 510(k) review, days · DJN

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

Recalls per year · DJN

No recall names DJN since 2007.

Adverse event reports per year · DJN

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

Planning a device in DJN? 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 DJN lately?

  • K823237Barbiturate Test Set #0550-050Stanbio Laboratory · 1982

The one DJN decision →

Related product codes

Other codes under 21 CFR 862.3150.

DKX Thin Layer Chromatography, BarbiturateDIS Enzyme Immunoassay, BarbituratePUY Test, Barbiturate, Employment And Insurance…PTH Test, Barbiturate, Over The CounterDLX Hemagglutination Inhibition, BarbiturateDKN Radioimmunoassay, BarbiturateKZY High Pressure Liquid Chromatography, BarbiturateDMF Gas Liquid Chromatography, Barbiturate