PMA P790019S010
- Device
- Abbott Imx(r) Havab(r)-m
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S010
- Decision date
- 1997-07-24
Current openFDA PMA Record
- Device
- ABBOTT IMX(R) HAVAB(R)-M
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S010
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 1997-07-24
- Decision code
- APPR
- Date received
- 1997-06-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN THE EVALUATION OF THE HAVAB-M EIA CONJUGATE CONCENTRATE, POSITIVE CONTROL FROM A SAMPLE TO STANDARD RATIO TO A SAMPLE TO TARGET RATIO.