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Food and Drug Administration

Hematology and Pathology Devices

July 18, 2008

BRIEFING INFORMATION

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

FDA Executive Summary and Panel Questions (pdf)

Hematology Spurious results (pdf)

IVD Characteristics (pdf)

Bibliography of Literature for ADCC panel (pdf)

ADCC Information for panel (pdf)

Page last updated July 7, 2008 kkhorizonal rule
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