National Institute of Standards and Technology / New Hampshire Avenue Document Control Center / / /
IndustryTerm
announcements concerning your device / animal products / manufacturing practice requirements / aqueous buffered solution / Real time stability studies / marketed predicate devices / manufacturing practice / Internet address http /
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 / Center for Devices and Radiological Health / 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
Silver Spring / Courtney H. Lias / KATHY CRUZ / / /
Position
Manager Phone / MANAGER 333 FISKE ST HOLLISTON MA / Director / QUALITY ASSURANCE MANAGER / Calibrator / Product Type Calibrator / known Calibrator / Envoy / /
Microsoft Word - ADVIA ISE Reagents-Resubmission 510k[removed]doc