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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK132929
Test Name FirstVitals Health and Wellness Inc. GlucoSec Mentor NFC Blood Glucose Monitoring System  
Manufacturer NameSD BIOSENSOR, INC.
Consumer Information Phone Number1(800)922-8844
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date11/09/2015
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K132929
Device Name SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM
Applicant
SD BIOSENSOR, INC.
27001 LA PAZ RD, SUITE 266B
MISSION VIEJO,  CA  92691
Applicant Contact Feng-Yu Lee
Correspondent
LK Consulting Group USA, Inc.
2651 E Chapman Ave Ste 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Date Received09/17/2013
Decision Date 08/05/2015
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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