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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K161533
FOIA Releasable 510(k) K161533
Device Name A1C EZ Glycohemoglobin Analysis System
Applicant
Biohermes Co., Ltd.
2f, 3f, No 136 Mashan Meiliang Rd.,
Binhu Dist
Wuxi,  CN JS510
Applicant Contact Rao Qiangying
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 2032, International Mayors Communication Ctr
# 55 Shizhou Middle Rd., Nanshan District
Shenzhen,  CN GD755
Correspondent Contact Field Fu
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJE  
Date Received06/02/2016
Decision Date 06/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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