AXSYM ANTI-HCV
FDA premarket approval P970027/S009 · decided 2010-09-20
Approval details
- PMA number
- P970027
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AXSYM ANTI-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories
- Date received
- 2010-08-23
- Decision date
- 2010-09-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- MODIFICATIONS TO THE QUALITY CONTROL TEST METHOD USED TO DETERMINE A SPECIFIC ATTRIBUTE OF THE AXSYM ANTI-HCV SOLUTION BASED COMPONENTS.
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