Cleared Traditional

Premier Resolution System

K222635 · Trinity Biotech (Primus Corporation, Dba Trinity Biotech) · Hematology

Aug 2023

Decision

338d

Days

Class 2

Risk

About This 510(k) Submission

K222635 is an FDA 510(k) clearance for the Premier Resolution System, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Trinity Biotech (Primus Corporation, Dba Trinity Biotech) (Kansas City, US). The FDA issued a Cleared decision on August 4, 2023, 338 days after receiving the submission on August 31, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number	K222635 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2022
Decision Date	August 04, 2023
Days to Decision	338 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF