FDA applicant
Intersep, Ltd.
FDA records 1 decision for Intersep, Ltd. (England, GB) in 1994: 1 510(k) clearance. All are in product code JJH (Clinical Sample Concentrator). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Intersep, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Intersep, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Intersep, Ltd.’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