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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

FDA Browser

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