FDA product code · Clinical chemistry

Nitrosalicylate Reduction, Amylase

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

CJDClass II21 CFR 862.1070510(k) required1 decision since 19960 recalls

1 FDA decision since 1996. 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 CJD 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 · CJD

FDA has decided no CJD device since 2007.

Median 510(k) review, days · CJD

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

Recalls per year · CJD

No recall names CJD since 2007.

Adverse event reports per year · CJD

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

Planning a device in CJD? 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 862.1070.

CIW Starch-Dye Bound Polymer, Amylase CJA Amyloclastic, Amylase CIK Radial Diffusion, Amylase KHM Nephelometric, Amylase JFJ Catalytic Methods, Amylase CIJ Saccharogenic, Amylase

Nitrosalicylate Reduction, Amylase

What has FDA decided in CJD lately?

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