FDA applicant
Primus Corporation Dba Trinity Biotech
FDA records 1 decision for Primus Corporation Dba Trinity Biotech (Kansas City, MO) in 2011: 1 510(k) clearance. All are in product code LCP (Assay, Glycosylated Hemoglobin). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Primus Corporation Dba Trinity Biotech’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Primus Corporation Dba Trinity Biotech’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 “Primus”
FDA records each applicant name separately; these may or may not be the same firm.