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IMMULITE 2000/2000 XPi Anti-HBc IgM

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: Siemens Healthcare Diagnostics Products, LTD
Trade Name: IMMULITE 2000 XPI ANTI-HBC IMG
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 7/26/2002
Days to Decision: 329 days
Decision Code: APPR
FDA Decision: Approval