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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BioHermes, A1C EZ Glycohemoglobin Analysis System, model A1C EZ 2.0
Classification Name: ASSAY, GLYCOSYLATED HEMOGLOBIN
Product Code: LCP
Device Class: 2
Regulation Number: 864.7470
Medical Specialty: Hematology
Registered Establishment Name: WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD.
Registered Establishment Number: 3012526002
Premarket Submission Number: K161533
Owner/Operator: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Owner/Operator Number: 10051365
Establishment Operations: Manufacturer
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