FDA product code · Immunology

Plates, Ouchterlony Agar

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

JZPClass I21 CFR 866.4600510(k) exempt1 decision since 19760 recalls

FDA lists JZP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision 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, immunology panel

Twenty years of JZP 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 · JZP

FDA has decided no JZP device since 2007.

Median 510(k) review, days · JZP

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

Recalls per year · JZP

No recall names JZP since 2007.

Adverse event reports per year · JZP

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

Planning a device in JZP? 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

Plates, Ouchterlony Agar

What has FDA decided in JZP lately?