PMA P790019S008

Device: ABBOTT IMX(R) HAVAB(R)-M
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S008
Product code: LOL
Decision date: 1997-03-27
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL FOR A CHANGE IN THE REFERENCE PANEL, TO REMOVE THE IGM ANTI-HBC POSITIVE PLASMA AND THE RHEUMATOID FACTOR POSITIVE PLASMA MIXED WITH HIGH TITER ANTI-HAV IGG POSITIVE PLASMA

Current openFDA PMA Record

Device: ABBOTT IMX(R) HAVAB(R)-M
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S008
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 1997-03-27
Decision code: APPR
Date received: 1997-01-31
Supplement type: Special (Immediate Track)
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE REFERENCE PANEL, TO REMOVE THE IGM ANTI-HBC POSITIVE PLASMA AND THE RHEUMATOID FACTOR POSITIVE PLASMA MIXED WITH HIGH TITER ANTI-HAV IGG POSITIVE PLASMA