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ABBOTT HBE (RDNA) EIA

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Abbott Laboratories
Trade Name
ABBOTT HBE DIAGNOSTIC KIT
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
7/15/1980
Days to Decision
286 days
Decision Code
APWD
FDA Decision
Withdrawal after approval