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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A1c Test System
510(k) Number K260468
Device Name H100Plus Hemoglobin Testing System
Applicant
Shenzhen Lifotronic Technology Co., Ltd.
Lifotronic Tower, # 8, Qiuzhi E. Rd.
Guancheng Community, Guanhu St., Longhua
Shenzhen,  CN 518110
Applicant Contact Xiang Lei
Correspondent
Guangdong Grzan Group Co., Ltd.
Rm2903, Building 1, No.160 Chuangtou Road,
Guangming District, Shenzhen, Guangdong
CN 518107
Correspondent Contact Lorna Li
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received02/12/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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