FDA product code · Microbiology

Antisera, Fluorescent, Sporothrix Schenekii

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

GMAClass I21 CFR 866.3680510(k) exempt1 decision since 19800 recalls

FDA lists GMA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1980. 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, microbiology panel

Twenty years of GMA 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 · GMA

FDA has decided no GMA device since 2007.

Median 510(k) review, days · GMA

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

Recalls per year · GMA

No recall names GMA since 2007.

Adverse event reports per year · GMA

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

Planning a device in GMA? 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

Antisera, Fluorescent, Sporothrix Schenekii

What has FDA decided in GMA lately?