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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK161738
Test Name ForaCare, Inc. FORA ADVANCED GD40 pro Blood Glucose and B-Ketone Monitoring System  
Manufacturer NameTAIDOC TECHNOLOGY CORPORATION
Consumer Information Phone Number(888)307-8188
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date04/07/2017
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K161738
Device Name FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
Applicant
TAIDOC TECHNOLOGY CORPORATION
6F, NO.127, WUGONG 2ND RD., WUGU DISTRICT
NEW TAIPEI CITY,  TW 24888
Applicant Contact PAUL LIU
Correspondent
TAIDOC TECHNOLOGY CORPORATION
6F, NO.127, WUGONG 2ND RD., WUGU DISTRICT
NEW TAIPEI CITY,  TW 24888
Correspondent Contact PAUL LIU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JIN   JJX   LFR  
Date Received06/23/2016
Decision Date 11/10/2016
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
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