ABBOTT IMX(R) HAVAB(R)-M
FDA premarket approval P790019/S009 · decided 1997-05-28
Approval details
- PMA number
- P790019
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Trade name
- ABBOTT IMX(R) HAVAB(R)-M
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 1997-04-23
- Decision date
- 1997-05-28
- Days to decision
- 35 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 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.
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