FDA product code · Immunology
Antinuclear Antibody, Antigen, Control
50 FDA decisions since 1983. 510(k) reviews decided 2021–2025 took a median of 488 days (half between 488 and 488). 11 recalls name this code, 0 of them Class I. The most-cited predicate is K954723, named by 11 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LKJ 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 · LKJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LKJ
Too few LKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKJ
2in 2018
MAUDE reports naming product code LKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 7 | 2 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in LKJ? 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) ReportRelated product codes
Other codes under 21 CFR 866.5100.