510(k) Report

FDA product code · Clinical toxicology

Test Reagents For Phenothiazine

DJQClass II21 CFR 862.3670510(k) required1 decision since 19900 recalls

1 FDA decision since 1990. 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 DJQ 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 · DJQ

FDA has decided no DJQ device since 2007.

Median 510(k) review, days · DJQ

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

Recalls per year · DJQ

No recall names DJQ since 2007.

Adverse event reports per year · DJQ

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

Planning a device in DJQ? 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