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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 K050224
Device Name 3TEST GLUCOSE MONITORING SYSTEM
Applicant
Neuero Engineering, Inc.
No 58, Fu-Chiun St.
Hsin-Chu City,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
Neuero Engineering, Inc.
No 58, Fu-Chiun St.
Hsin-Chu City,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received01/31/2005
Decision Date 07/13/2005
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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