Abbott Diabetes Care Ltd. / In Vitro Diagnostics / ABBOTT DIABETES CARE INC. / Ketone Control Solutions / K140371 Trade / EF Abbott Diabetes Care Inc. / 1 PSC Publishing / /
Currency
NAD / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / /
IndustryTerm
control solutions / announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / DIABETES CARE / manufacturing practice / Internet address http /
MedicalCondition
diabetes / ABBOTT DIABETES CARE / /
Organization
Division of Postmarket Surveillance / Division of Industry and Consumer Education / HUMAN SERVICES Public Health Service / Food and Drug 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 / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH’s office of Surveillance / Chemistry and Toxicology Devices Office / /
Person
MICHELLE RICAFORT / Silver Spring / Courtney H. Lias / / /
Position
Director / mediator / SENIOR REGULATORY AFFAIRS SPECIALIST / /
Product
Federal Food / /
ProvinceOrState
Maryland / California / /
Technology
radiation / 3 PRODUCT NAME CHARACTERISTICS Fundamental Technology / /
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