FDA applicant
Helena Laboratories Uk, Ltd.
FDA records 1 decision for Helena Laboratories Uk, Ltd. (Beaumont, TX) in 2012: 1 510(k) clearance. All are in product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A…). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Helena Laboratories Uk, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Helena Laboratories Uk, 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) ReportOther applicant names beginning “Helena”
FDA records each applicant name separately; these may or may not be the same firm.