510(k) Report

FDA product code · Clinical toxicology

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin

KZTClass II21 CFR 862.3450510(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 KZT 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 · KZT

FDA has decided no KZT device since 2007.

Median 510(k) review, days · KZT

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

Recalls per year · KZT

No recall names KZT since 2007.

Adverse event reports per year · KZT

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

Planning a device in KZT? 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 KZT lately?

  • K811067Bio-Bag TM Environmental Chamber Type MMarion Laboratories, Inc. · 1981

The one KZT decision →

Related product codes

Other codes under 21 CFR 862.3450.

KLO Enzymatic Radiochemical Assay, GentamicinDJI Antiserum, GentamicinDKD Bacillus Subtilis, Microbiological Assay…LCE Radioimmunoassay, Netilmicin (I-125)LCD Enzyme Immunoassay, GentamicinDNO Hemagglutination Inhibition, GentamicinLCQ Fluorescent Immunoassay GentamicinDJB Radioimmunoassay, Gentamicin (125-I), Second…