View ICR - OIRA Conclusion



0910-0594 201506-0910-020
Historical Active 201207-0910-004
HHS/FDA CBER
Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Extension without change of a currently approved collection   No
Regular
Approved without change 09/30/2015
06/29/2015
  Inventory as of this Action Requested Previously Approved
09/30/2018 36 Months From Approved 09/30/2015
4 0 4
20 0 20
0 0 0