FDA product code · Clinical chemistry

Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen

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

JNFClass I21 CFR 862.1590510(k) exempt1 decision since 19960 recalls

FDA lists JNF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 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 JNF 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 · JNF

FDA has decided no JNF device since 2007.

Median 510(k) review, days · JNF

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

Recalls per year · JNF

No recall names JNF since 2007.

Adverse event reports per year · JNF

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

Planning a device in JNF? 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

Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen

What has FDA decided in JNF lately?