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ARCHITECT HBSAG/HBSAG CONFIRMATORY

Page Type
PMA Approval
PDF
FDA Hosted PDF
* 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