FDA product code · Clinical chemistry

O-Phthalaldehyde, Urea Nitrogen

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

JGZClass II21 CFR 862.1770510(k) required11 decisions since 19770 recalls

11 FDA decisions since 1977. 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 JGZ 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 · JGZ

FDA has decided no JGZ device since 2007.

Median 510(k) review, days · JGZ

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

Recalls per year · JGZ

No recall names JGZ since 2007.

Adverse event reports per year · JGZ

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

Planning a device in JGZ? 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

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Other codes under 21 CFR 862.1770.

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O-Phthalaldehyde, Urea Nitrogen

What has FDA decided in JGZ lately?

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