FDA product code · Clinical chemistry

1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine

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

CDRClass I21 CFR 862.1730510(k) required1 decision since 19980 recalls

1 FDA decision since 1998. 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 chemistry panel

Twenty years of CDR 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 · CDR

FDA has decided no CDR device since 2007.

Median 510(k) review, days · CDR

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

Recalls per year · CDR

No recall names CDR since 2007.

Adverse event reports per year · CDR

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

Planning a device in CDR? 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

1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine

What has FDA decided in CDR lately?