FDA product code · Hematology

Cyanomethemoglobin Reagent And Standard Solution

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

GJZClass II21 CFR 864.7500510(k) required2 decisions since 19880 recalls

2 FDA decisions since 1988. 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, hematology panel

Twenty years of GJZ 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 · GJZ

FDA has decided no GJZ device since 2007.

Median 510(k) review, days · GJZ

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

Recalls per year · GJZ

No recall names GJZ since 2007.

Adverse event reports per year · GJZ

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

Planning a device in GJZ? 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

Related product codes

Other codes under 21 CFR 864.7500.

GKK Cyanomethemoglobin KHG Whole Blood Hemoglobin Determination LGL Assay, Bart'S, Hemoglobin GIG Hemoglobinometer GGF Acid Hematin GGZ Oxyhemoglobin GLY Oximeter To Measure Hemoglobin QGU Hemoglobin For Donor Testing

Cyanomethemoglobin Reagent And Standard Solution

What has FDA decided in GJZ lately?

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