FDA product code · Immunology

Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control

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

DFFClass II21 CFR 866.5080510(k) required1 decision since 19870 recalls

1 FDA decision since 1987. 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, immunology panel

Twenty years of DFF 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 · DFF

FDA has decided no DFF device since 2007.

Median 510(k) review, days · DFF

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

Recalls per year · DFF

No recall names DFF since 2007.

Adverse event reports per year · DFF

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

Planning a device in DFF? 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

Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control

What has FDA decided in DFF lately?