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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 K132663
Device Name I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Alliance International Co., Ltd.
#54 Ying Tao Rd.
Ying District
New Taipei City, 239,  TW 23942
Applicant Contact JEN KE-MIN
Correspondent
Alliance International Co., Ltd.
#54 Ying Tao Rd.
Ying District
New Taipei City, 239,  TW 23942
Correspondent Contact JEN KE-MIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/26/2013
Decision Date 04/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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