510(k) Report

FDA product code · Clinical toxicology

Radioimmunoassay, Phencyclidine

LCLClass U510(k) required11 decisions since 19790 recalls

11 FDA decisions since 1979. No recall names this code. The most-cited predicate is K011275, named by 2 later devices.

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 LCL 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 · LCL

FDA has decided no LCL device since 2007.

Median 510(k) review, days · LCL

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

Recalls per year · LCL

No recall names LCL since 2007.

Adverse event reports per year · LCL

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

Planning a device in LCL? 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