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FDA 510(k)

Premier Resolution System

K-Number: K222635 · 2023-08-04

ApplicantTrinity Biotech (Primus Corporation, Dba Trinity Biotech)
Decision Date2023-08-04
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Premier Resolution System is a medical device manufactured by Trinity Biotech (Primus Corporation, Dba Trinity Biotech). It received FDA 510(k) clearance on 2023-08-04 under approval number K222635. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Premier Resolution System?

Premier Resolution System is a medical device that received FDA 510(k) clearance on 2023-08-04. It is manufactured by Trinity Biotech (Primus Corporation, Dba Trinity Biotech). The 510(k) number is K222635.

When was Premier Resolution System approved by the FDA?

Premier Resolution System received FDA 510(k) clearance on 2023-08-04, under approval number K222635.

What company makes Premier Resolution System?

Premier Resolution System is manufactured by Trinity Biotech (Primus Corporation, Dba Trinity Biotech).

What is the FDA product code for Premier Resolution System?

The FDA product code for Premier Resolution System is GKA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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