FDA Browser

Last synced on 10 January 2025 at 11:05 pm

AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: SORIN BIOMEDICA, FIAT, USA, INC.
Trade Name: AB-CORE K HEPATITIS B CORE ANTIGEN 125I
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 2/17/1987
Days to Decision: 91 days
Decision Code: APPR
FDA Decision: Approval