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ABBOTT HBE (RDNA) EIA

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: Abbott Laboratories
Trade Name: ABBOTT HBE DIAGNOSTIC KIT
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 7/15/1980
Days to Decision: 286 days
Decision Code: APWD
FDA Decision: Withdrawal after approval