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Immunology Devices Panel Meeting
December 3, 2008
The statements contained in this document(s) are those of the product’s sponsor, not FDA and FDA does not necessarily agree with the sponsor’s statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
FDA Briefing Document (pdf)
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 spaces on the screen or on the printed page.
Sponsors Clinical Study Report (pdf)
Proposed HE4 Package Insert. (pdf)
Architect CA125II Package Insert (pdf)