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Advisory Committees
2009 Meeting Materials of the Hematology and Pathology Devices Panel
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October 22 & 23, 2009 Meeting Materials
- Agenda (October 22 & 23, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 77KB)
- Panel Roster (October 22 & 23, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 77KB)
- Bibliography (October 22 & 23, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 94KB)
- FDA Briefing Document (October 22 & 23, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 139KB)
- FDA Executive Summary (October 22 & 23, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 68KB)
- Questions (October 22 & 23, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 78KB)
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July 17, 2009 Meeting Materials
- July 17, 2009: Hematology and Pathology Devices Panel Meeting Announcement
- Agenda (July17, 2008: Hematology and Pathology Devices Panel Meeting) (PDF - 62KB)
- Panel Roster (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 67KB)
- Bibliography (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 76KB)
- FDA Briefing Document CLIA HemoCue (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 274KB)
- FDA Draft Panel Questions (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 47KB)
- FDA Exeutive Summary (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 89KB)
- HemoCue WBC CLIA Waiver (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 731KB)
- HemoCue WBC CLIA Waiver Attachment (July 17, 2009: Hematology and Pathology Panel Meeting) (PDF - 181KB)
- CLIA Waiver Response 1 (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 150KB)
- CLIA Waiver Response 2 (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 312KB)
- HemoCue WBC CLIA Waiver Raw Data from Field Study (March 17, 2009: Hematology and Pathology Devices Panel Meeting) (XLS - 163KB)
- 24 Hour Summary (July 17, 2009: Hematology and Pathology Devices Panel Meeting) (PDF - 64KB)
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