FDA product code · Clinical chemistry

Radioimmunoassay, Thyroxine-Binding Globulin

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

CEEClass II21 CFR 862.1685510(k) exempt25 decisions since 19760 recalls

FDA lists CEE as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 25 FDA decisions since 1976. 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 CEE 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 · CEE

FDA has decided no CEE device since 2007.

Median 510(k) review, days · CEE

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

Recalls per year · CEE

No recall names CEE since 2007.

Adverse event reports per year · CEE

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

Planning a device in CEE? 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, Thyroxine-Binding Globulin

What has FDA decided in CEE lately?