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Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle DRAFT GUIDANCE

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Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle DRAFT GUIDANCE
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:
Guidance for Industry and FDA Staff DRAFT
Inhalt:
Zusätzlicher Guidance als Kontrollleitfaden bei der Reklssifizierung von Klasse 3 nach Klass 2 von automatisierten Blut Zell Separatoren.

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