510(k) Report

FDA product code · Clinical toxicology

Gas Chromatography, Phenobarbital

DJHClass II21 CFR 862.3660510(k) required1 decision since 19840 recalls

1 FDA decision since 1984. 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 DJH 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 · DJH

FDA has decided no DJH device since 2007.

Median 510(k) review, days · DJH

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

Recalls per year · DJH

No recall names DJH since 2007.

Adverse event reports per year · DJH

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

Planning a device in DJH? 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 DJH lately?

  • K843440Mingo Log 7Siemens Elema AB · 1984

The one DJH decision →

Related product codes

Other codes under 21 CFR 862.3660.

DKP Radioimmunoassay, PhenobarbitalDOO Liquid Chromatography, PhenobarbitalLGQ Fluorescence Polarization Immunoassay…DLZ Enzyme Immunoassay, PhenobarbitalLET Fluorescent Immunoassay, PhenobarbitalLFN Nephelometric Inhibition Immunoassay…DIX Thin Layer Chromatography, PhenobarbitalLDA U.V. Spectrometry, Phenobarbital