View ICR - OIRA Conclusion



0910-0594 201207-0910-004
Historical Active 200908-0910-003
HHS/FDA
Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle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 08/15/2012
07/17/2012
  Inventory as of this Action Requested Previously Approved
08/31/2015 36 Months From Approved 09/30/2012
4 0 4
20 0 20
0 0 0