CLOROX / i-SENS Inc. / In Vitro Diagnostics / K130696 Trade / Device Name Trade / i-SENS Inc C / Submitter i-SENS Inc. / senS i-SENS Inc. / i-SFNS Inc. / /
Country
Korea / /
Event
FDA Phase / /
Facility
New Hamrpshire Avenue Document Control Center / /
IndustryTerm
candidate devices / predicate device use same control solutions / wireless uploading / candidate device / control solutions / announcements concerning your device / predicate device / manufacturing practice requirements / Internet address littp /
MedicalCondition
hepatitis B3 virus / diabetes / /
Organization
Division of Postmarket Surveillance / Korea Public Health Service / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / New Hamrpshire Avenue Document Control Center / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Chemistry / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use Form / CDRH's office of Surveillance / Environmental Protection Agency / Center for Devices / Chemistry and Toxicology Devices Office / /
Person
Silver Spring / Yun Lim Prepared / Courtney H. Lias / Yuri Lim / Carol C.Benson / Yun Lim / / /
Position
Director / /
Product
Federal Food / /
ProvinceOrState
Maryland / /
Technology
radiation / Fundamental scientific technology / Bluetooth / electrochemical biosensor technology / /
R/309Q i-SFNS, Inc. :Iefl[removed]Owangun-ro, Nowon-gu, Seoul[removed], Korea