ABBOTT IMX(R) HAVAB(R)-M
FDA premarket approval P790019/S010 · decided 1997-07-24
Approval details
- PMA number
- P790019
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT IMX(R) HAVAB(R)-M
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 1997-06-20
- Decision date
- 1997-07-24
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- 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.
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