ABBOTT AXSYM ANTI-HCV
FDA premarket approval P970027/S003 · decided 2004-12-14
Approval details
- PMA number
- P970027
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Trade name
- ABBOTT AXSYM ANTI-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories
- Date received
- 2004-11-18
- Decision date
- 2004-12-14
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
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