Feature Same Siemens Healthcare Diagnostics / K140717 Trade / In Vitro Diagnostics / SIEMENS HEALTHCARE DIAGNOSTICS INC. / Submitter Information Owner Siemens Healthcare Diagnostics Inc. / Cloudy Siemens Healthcare Diagnostics / Number K932674 Manufacturer Siemens Healthcare Diagnostics / Same Siemens Healthcare Diagnostics / / /
Event
FDA Phase / /
Facility
National Institute of Standards and Technology / New Hampshire Avenue Document Control Center / /
IndustryTerm
announcements concerning your device / hospital network / manufacturing practice requirements / diagnostic product / marketed predicate devices / manufacturing practice / Internet address http /
MedicalCondition
diabetes mellitus / /
Organization
National Institute of Standards and Technology / Division of Postmarket Surveillance / Division of Industry and Consumer Education / HUMAN SERVICES Public Health Service / Food and Drug Administration / Radiological Health Center for Devices and Radiological Health Enclosure / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Division of Chemistry / CDRH’s office of Surveillance / Chemistry and Toxicology Devices Office / /
Person
Silver Spring / SUSAN TIBEDO SR. / Noor Malki / Courtney H. Lias / Susan Tibedo / Semi-Quantitative Qualitative Negative Negative Negative / / /
Position
Director / VP / Clinical / SR. MANAGER REGULATORY AFFAIRS / calibrator / test system Calibrator / Manager Regulatory Affairs susan.tibedo@siemens.com / JIX Calibrator / /
Siemens Healthcare Diagnostics Inc