AXSYM HAVAB 2.0
FDA premarket approval P780012/S014 · decided 2004-07-30
Approval details
- PMA number
- P780012
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AXSYM HAVAB 2.0
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2004-07-22
- Decision date
- 2004-07-30
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
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