FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Titel:
FDA Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Internet:
Herkunft/Verlag:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078732.pdf
Dokumentenart:
Leitfaden für die Industrie
Inhalt:
Leitfaden zur Klassifizierung und den Risiken automatisierter Verfahren zur Blutzellseparation.