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AXSYM HBSAG/HBSAG CONFIRMATORY

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: ABBOTT LABORATORIES INC
Trade Name: AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 6/1/2006
Days to Decision: 177 days
Decision Code: APWD
FDA Decision: Withdrawal after approval