FDA applicant
Leica Biosystems Newcastle, Ltd.
FDA records 6 decisions for Leica Biosystems Newcastle, Ltd. (Newcastle Upon Tyne, GB) from 2014 to 2023: 6 510(k) clearances. Most are in product codes MXZ (Immunohistochemistry Assay, Antibody…) and MYA (Immunohistochemistry Antibody Assay, Estrogen…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Leica Biosystems Newcastle, Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Leica Biosystems Newcastle, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Leica Biosystems Newcastle, 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 “Leica”
FDA records each applicant name separately; these may or may not be the same firm.