View ICR - OIRA Conclusion



0910-0594 200908-0910-003
Historical Active 200606-0910-002
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Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle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 09/15/2009
08/10/2009
  Inventory as of this Action Requested Previously Approved
09/30/2012 36 Months From Approved 09/30/2009
4 0 4
20 0 20
0 0 0