PMA P820060S026
- Device
- AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S026
- Product code
- LOK
- Decision date
- 2011-05-20
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
Current openFDA PMA Record#
- Device
- AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S026
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- 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.