DEVICE: ABBOTT AXSYM HAVAB-M 2.0
FDA premarket approval P790019/S018 · decided 2004-06-16
Approval details
- PMA number
- P790019
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Trade name
- DEVICE: ABBOTT AXSYM HAVAB-M 2.0
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2004-05-21
- Decision date
- 2004-06-16
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- Statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
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