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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K121706
Device Name FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Foracare, Inc.
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact PINJUNG CHEN
Correspondent
Foracare, Inc.
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact PINJUNG CHEN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received06/08/2012
Decision Date 01/14/2013
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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