II Control Solutions / K133741 Trade / In Vitro Diagnostics / 1 PSC Publishing / Contact Roche Diagnostic Corporation / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / Bar Code Scanner None Present Transmission / port Measuring Range / /
IndustryTerm
announcements concerning your device / lithium technology / predicate device / manufacturing practice requirements / marketed predicate devices / healthcare settings / manufacturing practice / Internet address http /
MedicalCondition
diabetes / /
Organization
Division of Postmarket Surveillance / Division of Industry and Consumer Education / HUMAN SERVICES Public Health Service / mg/dL Intravenous administration / Food and Drug Administration / Center for Devices and Radiological Health / Intravenous administration / Radiological Health Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Division of Chemistry / CDRH’s office of Surveillance / Devices and Radiological Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / Chemistry and Toxicology Devices Office / /
Person
Nathan Carrington / Silver Spring / Lot-Release Criteria Same / Katherine Serrano / Courtney H. Lias / / /
Position
DIRECTOR OF REGULATORY AFFAIRS / Director / /
Product
CHEK Inform II / Federal Food / /
ProvinceOrState
Maryland / /
Technology
radiation / Bar Code / lithium technology / WLAN / fundamental scientific technology / integrated circuits / /
Performa 510(k) Summary Statement_Revised