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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K032029
Device Name BTG SMARTEST GLUCOSE TEST SYSTEM
Applicant
Bt Medical
6f-5 # 210 38th Rd.
Taichung Industrial Park
Taichung,  TW
Applicant Contact DEBBIE CHENG
Correspondent
Bt Medical
6f-5 # 210 38th Rd.
Taichung Industrial Park
Taichung,  TW
Correspondent Contact DEBBIE CHENG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JJX  
Date Received07/01/2003
Decision Date 12/18/2003
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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