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510(k) Data Aggregation
K Number
K112015Device Name
PREMIER HB9210 HBA1C ANALYZER
Manufacturer
PRIMUS CORPORATION DBA TRINITY BIOTECH
Date Cleared
2011-11-22
(132 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
PRIMUS CORPORATION DBA TRINITY BIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Premier Hb9210™ system is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human capillary and venous whole blood. HbA1c is used for the monitoring of long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only.
Device Description
The Premier Hb9210™ is an update of the predicate HPLC device, the Ultra2, which is the current model under K891235. The Premier Hb9210™ is a compact, integrated HPLC system and workstation with the Trinity Biotech AFFINITY Software for the quantitative determination of glycated hemoglobin using the patented boronate affinity chemistry with high performance liquid chromatography.
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