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Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
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City
Rockville /
/
Facility
Rockville Pike /
/
IndustryTerm
automated blood cell separator device /
device /
blood cell separator devices /
Internet athttp /
MedicalCondition
injury /
seizures /
operator infection /
shock /
cardiac arrhythmias /
tetany /
thrombosis /
air embolism /
serious injuries /
infectious disease /
sepsis /
/
MedicalTreatment
apheresis /
/
Organization
FDA /
U.S. Department of Health and Human Services /
Food and Drug Administration Center for Biologics Evaluation and Research /
office of Communication /
Outreach and Development /
office of Management and Budget /
U.S. Department of Health /
/
/
ProvinceOrState
Maryland /
/
URL
www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformati /
/
SocialTag
Food and Drug Administration
Medical device
Medical equipment
Medical technology
Premarket approval
Separator
Apheresis
Blood donation
Federal Food, Drug, and Cosmetic Act
Medicine