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510(k) Data Aggregation
K Number
K161533Device Name
A1C EZ Glycohemoglobin Analysis System
Manufacturer
Date Cleared
2017-06-16
(379 days)
Product Code
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
BioHermes Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A1C EZ Glycohemoglobin Analysis System is an in vitro diagnostic test used to quantitatively measure the percent glycohemoglobin Alc or glycohemoglobin A1c fraction mmol/mol in venous whole blood samples. This system is intended for multiple patient use to monitor long term glycemic control in individuals previously diagnosed with diabetes. This test is not to be used for screening or diagnosis of diabetes or for neonatal use. The A1C EZ Glycohemoglobin Analysis System is intended for professional use in clinical laboratories only.
Device Description
This product is used to quantitatively measure the percent glycohemoglobin A1c or glycohemoglobin A1c fraction mmol/mol in human whole blood sample.
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