FDA product code · Clinical chemistry

Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids

Name: FDA decisions, review times, recalls and adverse event reports for product code KWX
Creator: 510(k) Report

KWXClass II21 CFR 862.1187510(k) required2 decisions since 19980 recalls

2 FDA decisions since 1998. 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 chemistry panel

Twenty years of KWX 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 · KWX

FDA has decided no KWX device since 2007.

Median 510(k) review, days · KWX

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

Recalls per year · KWX

No recall names KWX since 2007.

Adverse event reports per year · KWX

No MAUDE report names KWX since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — KWX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KWX? 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

Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids

What has FDA decided in KWX lately?