510(k) Report

FDA product code · Clinical toxicology

Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol

DOGClass II21 CFR 862.3320510(k) required5 decisions since 19760 recalls

5 FDA decisions since 1976. 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, clinical toxicology panel

Twenty years of DOG 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 · DOG

FDA has decided no DOG device since 2007.

Median 510(k) review, days · DOG

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

Recalls per year · DOG

No recall names DOG since 2007.

Adverse event reports per year · DOG

No MAUDE report names DOG since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DOG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DOG? 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 862.3320.