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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK100322
Test Name Nurse Rosie Products, Rosie RealTime Blood Glucose Monitoring System  
Manufacturer NameTaidoc Technology Corporation
Consumer Information Phone Number1(800)841-1109
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date08/17/2018
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K100322
Device Name TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
Applicant
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 248
Applicant Contact DEBRA LIANG
Correspondent
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 248
Correspondent Contact DEBRA LIANG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received02/04/2010
Decision Date 06/28/2010
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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