510(k) Report

FDA product code · Clinical toxicology

High Pressure Liquid Chromatography, Benzodiazepine

LAAClass II21 CFR 862.3170510(k) required1 decision since 19960 recalls

1 FDA decision since 1996. 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 LAA 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 · LAA

FDA has decided no LAA device since 2007.

Median 510(k) review, days · LAA

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

Recalls per year · LAA

No recall names LAA since 2007.

Adverse event reports per year · LAA

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

Planning a device in LAA? 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 LAA lately?

  • K955116Benzodiazepines by Remedi HSBio-Rad · 1996

The one LAA decision →

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Other codes under 21 CFR 862.3170.

KZZ Gas Chromatography, BenzodiazepineJXM Enzyme Immunoassay, BenzodiazepinePUZ Test, Benzodiazepine, Employment And Insurance…NFV Test, Benzodiazepine, Over The CounterLAB Thin Layer Chromatography, Benzodiazepine