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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K260738
Device Name Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
Applicant
Changsha Sinocare, Inc.
#265 Guyuan Rd., Hi-Tech Zone
Changsha, Hunan,  CN 410205
Applicant Contact Qian Zhou
Correspondent
Changsha Sinocare, Inc.
#265 Guyuan Rd., Hi-Tech Zone
Changsha, Hunan,  CN 410205
Correspondent Contact Jiangqin Zhao
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/06/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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