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510(k) K222635

Premier Resolution System by Trinity Biotech (Primus Corporation, Dba Trinity Biotech) — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2023
Date Received
August 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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