FDA product code · Clinical chemistry

Amyloclastic, Amylase

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

CJAClass II21 CFR 862.1070510(k) required10 decisions since 19840 recalls

10 FDA decisions since 1984. 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 CJA 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 · CJA

FDA has decided no CJA device since 2007.

Median 510(k) review, days · CJA

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

Recalls per year · CJA

No recall names CJA since 2007.

Adverse event reports per year · CJA

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

Planning a device in CJA? 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 CJD Nitrosalicylate Reduction, Amylase CIK Radial Diffusion, Amylase KHM Nephelometric, Amylase JFJ Catalytic Methods, Amylase CIJ Saccharogenic, Amylase

Amyloclastic, Amylase

What has FDA decided in CJA lately?

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