510(k) Report

FDA product code · Clinical toxicology

Cyclosporine Radioimmunoassay

LTBClass II21 CFR 862.1235510(k) required1 decision since 19810 recalls

1 FDA decision since 1981. 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 LTB 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 · LTB

FDA has decided no LTB device since 2007.

Median 510(k) review, days · LTB

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

Recalls per year · LTB

No recall names LTB since 2007.

Adverse event reports per year · LTB

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

Planning a device in LTB? 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 LTB lately?

  • K813523Electric Self Sterilization Inocul. LoopTechhnilab Instruments, Inc. · 1981

The one LTB decision →

Related product codes

Other codes under 21 CFR 862.1235.

MGV Radioimmunoassay For CyclosporineMGU Fluorescence Polarization Immunoassay For…MKW CyclosporineMAR Cyclosporine And Metabolites Serum AssayMGS High Performance Liquid Chromatography For…