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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK090404
Test Name Fora Care, Inc., FORA V10 Blood Glucose Monitoring System  
Manufacturer NameTaidoc Technology Corporation
Consumer Information Phone Number(888)307-8188
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date07/16/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K090404
Device Name FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
Applicant
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 241
Applicant Contact Yuhua Chen
Correspondent
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 241
Correspondent Contact Yuhua Chen
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received02/17/2009
Decision Date 06/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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