K132288 Trade / CLOROX / M02 I-SENS INC. / Radiological Health / In Vitro Diagnostics / Device Name Trade / Submitter i-SENS Inc. / i-SENS Inc. / /
Event
FDA Phase / /
IndustryTerm
candidate device / control solutions / announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / healthcare settings / Internet address htto3 /
MedicalCondition
HBV / diabetes / hepatitis B / /
MedicalTreatment
CPR / /
Organization
Division of Postmarket Surveillance / CDRHK Office / office of Surveillance / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Chemistry / Center for Devices and Radiological Health Enclosure Indications / Environmental Protection Agency / Chemistry and Toxicology Devices Office / /
Person
Yuri Lim / H. Lias / Carol C.Benson -Sfor / Yun Lim / / /
(- ml i-SENS, Inc[removed], Gwangun-ro, Nowon-gu, Seoul[removed], Korea Tel[removed]