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Document NumberK083664
Test Name Fora Care Inc. FORA TD-4245 Blood Glucose Monitoring System  
Manufacturer NameTaidoc Technology Corporation
Consumer Information Phone Number1(805)230-3068
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date01/12/2009
Device Classification Name Glucose Oxidase, Glucose
510(k) Number K083664
Device Name FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
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
CGA  
Subsequent Product Code
NBW  
Date Received12/10/2008
Decision Date 01/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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