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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 K130657
Device Name LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
Applicant
All Medicus Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Applicant Contact Priscilla Chung
Correspondent
All Medicus Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received03/12/2013
Decision Date 07/15/2013
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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