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ARCHITECT HBSAG/HBSAG CONFIRMATORY

Page Type: PMA Approval
PDF: Full PDF / Letter
* The FDA doesn't provide PDFs for all submissions.
Applicant: Abbott Laboratories
Trade Name: ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 9/7/2006
Days to Decision: 195 days
Decision Code: APWD
FDA Decision: Withdrawal after approval

FDA Browser

ARCHITECT HBSAG/HBSAG CONFIRMATORY

Page Type: PMA Approval
PDF: Full PDF / Letter
* The FDA doesn't provide PDFs for all submissions.
Applicant: Abbott Laboratories
Trade Name: ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 9/7/2006
Days to Decision: 195 days
Decision Code: APWD
FDA Decision: Withdrawal after approval