K222635

Substantially Equivalent

Premier Resolution System

Applicant: Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
Product code: GKA
Advisory panel: Hematology
Date received: 2022-08-31
Decision date: 2023-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.