PMA P790019S009

Device: ABBOTT IMX(R) HAVAB(R)-M
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S009
Product code: LOL
Decision date: 1997-05-28
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL FOR A CHANGE IN THE SPECIFICATIONS FOR THE POSITIVE CONTROL SAMPLE TO STANDARD RATIO FROM 0.90-1.15 TO 0.85-1.15, AND A CHANGE IN THE EVALUATION OF THE HEPATITIS A VIRUS SOLUTION AND THE HAVAB(R)-M EIA CONJUGATE FROM A SAMPLE TO STANDARD RATIO TO A SAMPLE TO TARGET RATIO.

Current openFDA PMA Record

Device: ABBOTT IMX(R) HAVAB(R)-M
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S009
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 1997-05-28
Decision code: APPR
Date received: 1997-04-23
Supplement type: Special (Immediate Track)
Approval order statement: APPROVAL FOR A CHANGE IN THE SPECIFICATIONS FOR THE POSITIVE CONTROL SAMPLE TO STANDARD RATIO FROM 0.90-1.15 TO 0.85-1.15, AND A CHANGE IN THE EVALUATION OF THE HEPATITIS A VIRUS SOLUTION AND THE HAVAB(R)-M EIA CONJUGATE FROM A SAMPLE TO STANDARD RATIO TO A SAMPLE TO TARGET RATIO.