510(k) Report

FDA product code · Clinical toxicology

Column Supports, Glc

DJAClass I21 CFR 862.2250510(k) exempt1 decision since 19800 recalls

FDA lists DJA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1980. 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 DJA 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 · DJA

FDA has decided no DJA device since 2007.

Median 510(k) review, days · DJA

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

Recalls per year · DJA

No recall names DJA since 2007.

Adverse event reports per year · DJA

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

Planning a device in DJA? 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 DJA lately?

  • K801833Gas-Chromatographic PackingSupelco, Inc. · 1980

The one DJA decision →

Related product codes

Other codes under 21 CFR 862.2250.

DMS Gases, GlcDII Columns, GlcDLG Coating, Liquid, GlcKZQ Chromatography (Gas), Clinical UseJXQ Monitor, U.V., GlcJSQ Chromatography For Bacterial Identification