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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK161299
Test Name Medline Industries Inc., Harmony Blood Glucose Monitoring System  
Manufacturer NameAPEX BIOTECHNOLOGY CORP.
Consumer Information Phone Number(866)274-2131
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date11/06/2019
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K161299
Device Name BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
Applicant
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V
HSINCHU SCIENCE PARK
Hsinchu,  TW 30078
Applicant Contact Hsue-mei Lee
Correspondent
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V
HSINCHU SCIENCE PARK
Hsinchu,  TW 30078
Correspondent Contact Hsue-mei Lee
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received05/09/2016
Decision Date 12/23/2016
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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