FDA product code · Pathology
Immunohistochemistry Assay, Antibody, Folr1
1 FDA decision since 2022. No recall names this code.
The FOLR1 antibody is a qualitative immunohistochemical antibody intended to identify FOLR1 protein expression in human clinical tissue specimens. The FOLR-1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QUL 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 · QUL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QUL
Too few QUL 510(k)s in any year since 2007 to give a median.
Recalls per year · QUL
No recall names QUL since 2007.
Adverse event reports per year · QUL
1in 2024
MAUDE reports naming product code QUL, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QUL? 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 864.1860.