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ARCHITECT CORE / Alinity i Anti-HBc

Page Type: PMA Approval
PDF: Full PDF / Letter
* The FDA doesn't provide PDFs for all submissions.
Applicant: Abbott Laboratories
Trade Name: ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 4/10/2009
Days to Decision: 225 days
Decision Code: APPR
FDA Decision: Approval

FDA Browser

ARCHITECT CORE / Alinity i Anti-HBc

Page Type: PMA Approval
PDF: Full PDF / Letter
* The FDA doesn't provide PDFs for all submissions.
Applicant: Abbott Laboratories
Trade Name: ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 4/10/2009
Days to Decision: 225 days
Decision Code: APPR
FDA Decision: Approval