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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 K171785
Device Name WowGoHealth Blood Glucose Monitoring System
Applicant
Biotest Medical Corporation
# 3-2, Chien-Kuo Rd.
Tepz Tantzu Dist.
Taichung,  TW 42760
Applicant Contact Fred Lee
Correspondent
Biotest Medical Corporation
# 3-2, Chien-Kuo Rd.
Tepz Tantzu Dist.
Taichung,  TW 42760
Correspondent Contact Fred Lee
Regulation Number862.1345
Classification Product Code
NBW  
Date Received06/15/2017
Decision Date 09/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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