Last synced on 30 November 2024 at 11:09 am

AXSYM CORE-M 2.0

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ABBOTT LABORATORIES INC
Trade Name
AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
8/25/2006
Days to Decision
168 days
Decision Code
APWD
FDA Decision
Withdrawal after approval