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Biology / Glucose meter / Medical device / Blood sugar / Blood glucose monitoring / Glucose test / Diabetes management / Blood lancet / Wolgye-dong / Medicine / Diabetes / Blood tests


i-SENS, Inc. kCI>SefS[removed]Wolgye-dong, Nowon-gu, Seoul[removed], Korea
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Document Date: 2012-10-09 13:29:22

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City

SEOUL / /

Company

CLOROX / i-SENS Inc. / AUTO-CHEK Control Solutions / e1S i-SFNS Inc. / /

Country

South Korea / /

/

Event

FDA Phase / /

IndustryTerm

candidate device / announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address / fundamental scientific technology / scientific technology / /

MedicalCondition

HBV / diabetes / hepatitis B / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / CDRH's office of Surveillance Biometrics/Division / office of InVitro Diagnostic Devices / In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological / office of Surveillance and Biometric / DivisinSgtOf Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Chemistry / Environmental Protection Agency / Chemistry and Toxicology Devices Office / /

Person

Qy H. Lias / Hyun Joon Oh / /

/

Position

Division Manager / Quality Assurance / /

Product

Federal Food / /

ProvinceOrState

Maryland / /

Technology

same fundamental scientific technology / /

URL

www.fda.Rov/MedicaI / www.fda.gov/MedicalDevices/ResourcesforYoudlnduistry/default.htm / www.i-sens.com / /

SocialTag