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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK101631
Test Name MPA-Diabetic, Inc. CHOICE DM® Complete by FORA GD20 Blood Glucose Monitoring System, model FORA GD20  
Manufacturer NameTaidoc Technology Corporation
Consumer Information Phone Number1(888)307-8188
Test TypeGlucose monitoring devices (prescription use only)
Effective Date09/09/2011
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K101631
Device Name FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Taidoc Technology Corporation
3f, 5f, No 127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Applicant Contact TELING HSU
Correspondent
Taidoc Technology Corporation
3f, 5f, No 127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Correspondent Contact TELING HSU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received06/10/2010
Decision Date 09/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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