FDA product code · Hematology

Antigen, Antiserum, Control, Antithrombin Iii

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

DDQClass II21 CFR 864.7060510(k) required4 decisions since 19780 recalls

4 FDA decisions since 1978. 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 DDQ 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 · DDQ

FDA has decided no DDQ device since 2007.

Median 510(k) review, days · DDQ

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

Recalls per year · DDQ

No recall names DDQ since 2007.

Adverse event reports per year · DDQ

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

Planning a device in DDQ? 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 864.7060.

JBQ Antithrombin Iii Quantitation JPE Antithrombin Iii, Two Stage Clotting Time Assay

Antigen, Antiserum, Control, Antithrombin Iii

What has FDA decided in DDQ lately?

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