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Zdrowie i gospodarka · 30/11/2007

FDA Publishes Guidance Document for Automated Blood Cell Separator Devices

The Food and Drug Administration (FDA) has released a guidance document outlining the special controls for automated blood cell separator devices operating by centrifugal or filtration separation principle, intended for routine blood collection and compliance with class II device regulations.

Source: Federal Register — Food and Drug AdministrationOpen original release →