PMA P970027S011
- Device
- AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S011
- Product code
- MZO
- Decision date
- 2011-05-20
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
Current openFDA PMA Record
- Device
- AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S011
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-05-20
- Decision code
- APPR
- Date received
- 2010-11-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.