Documento fuente o registro público
FDA 510(k) K222635 — Premier Resolution System
FDA 510(k) index record K222635. Device: Premier Resolution System. Applicant as listed: Trinity Biotech (Primus Corporation, Dba Trinity Biotech). Decision date: 2023-08-04.
Fuente
"device_name": "Premier Resolution System"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-29
professional use
FDA 510(k) public index record K222635.
Device name: Premier Resolution System. Applicant as listed: Trinity Biotech (Primus Corporation, Dba Trinity Biotech).
Decision date: 2023-08-04. Decision wording: Substantially Equivalent.
Product code: GKA. Regulation: 21 CFR 864.7415. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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