FDA applicant
Trinity Biotech, Plc
FDA records 12 decisions for Trinity Biotech, Plc (Jamestown, NY) from 1997 to 2017: 12 510(k) clearances. Most are in product codes LIP (Enzyme Linked Immunoabsorption Assay…) and LSR (Reagent, Borrelia Serological Reagent). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Trinity Biotech”, “Trinity Biotech, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Trinity Biotech, Plc’s devices, and how often a recall has named them.
FDA decisions per year
2in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Trinity Biotech, Plc’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 “Trinity”
FDA records each applicant name separately; these may or may not be the same firm.