FDA product code · Immunology

Igg (Fd Fragment Specific), Antigen, Antiserum, Control

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

DAQClass I21 CFR 866.5540510(k) exempt1 decision since 19890 recalls

FDA lists DAQ 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 1989. 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 DAQ 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 · DAQ

FDA has decided no DAQ device since 2007.

Median 510(k) review, days · DAQ

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

Recalls per year · DAQ

No recall names DAQ since 2007.

Adverse event reports per year · DAQ

1in 2025

2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code DAQ, not matched to any one device; reports are not rates.

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	—	1
2026	—	—

FIG. 1 — DAQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DAQ? 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

Igg (Fd Fragment Specific), Antigen, Antiserum, Control

What has FDA decided in DAQ lately?