FDA applicant
Veridex, LLC
FDA records 12 decisions for Veridex, LLC (Raritan, NJ) from 2004 to 2013: 12 510(k) clearances. Most are in product codes NQI (System, Immunomagnetic, Circulating Cancer…) and GKH (Apparatus, Automated Blood Cell Diluting). Its devices cite 10 predicates, 6 of them its own earlier devices. 10 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Veridex, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Veridex, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report