Last synced on 6 December 2024 at 11:05 pm

AXSYM HBSAG/HBSAG CONFIRMATORY

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ABBOTT LABORATORIES INC
Trade Name
AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
6/1/2006
Days to Decision
177 days
Decision Code
APWD
FDA Decision
Withdrawal after approval