PMA P790025S007

Device: ABBOTT HBE (RDNA) EIA TEST KIT
Applicant: Abbott Laboratories
PMA number: P790025
Supplement: S007
Product code: LOM
Decision date: 1996-02-16
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS FROM THE USE OF RECALCIFIED ANTI-HBE POSITIVE HUMAN PLASMA FROM ONE DONOR TO THE USE OF AN ALTERNATE SOURCE OF ANTI-HBE POSITIVE PLASMA FOR BEAD COATING

Current openFDA PMA Record

Device: ABBOTT HBE (RDNA) EIA TEST KIT
Applicant: Abbott Laboratories
PMA number: P790025
Supplement: S007
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 1996-02-16
Decision code: APPR
Date received: 1995-02-21
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS FROM THE USE OF RECALCIFIED ANTI-HBE POSITIVE HUMAN PLASMA FROM ONE DONOR TO THE USE OF AN ALTERNATE SOURCE OF ANTI-HBE POSITIVE PLASMA FOR BEAD COATING