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FDA 510(k), K161533, A1C EZ Glycohemoglobin Analysis System
FDA 510(k), K161533, A1C EZ Glycohemoglobin Analysis System
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$149.00 USD
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$149.00 USD
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510(K) Number: K161533
Device Name: A1C EZ Glycohemoglobin Analysis System
Manufacturer:
Device Classification Name: Assay, Glycosylated Hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 06/02/2016
Decision Date: 06/16/2017
Regulation Medical Specialty: Hematology
Device Name: A1C EZ Glycohemoglobin Analysis System
Manufacturer:
Device Classification Name: Assay, Glycosylated Hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 06/02/2016
Decision Date: 06/16/2017
Regulation Medical Specialty: Hematology
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