PMA P120008S010
- Device
- ABBOTT ARCHITECT AFP ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S010
- Product code
- LOK
- Decision date
- 2016-10-27
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Abbott Laboratories requests approval to transfer the manufacturing and testing of two monoclonal antibodies from one Abbott manufacturing site to another.
Current openFDA PMA Record#
- Device
- ABBOTT ARCHITECT AFP ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S010
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2016-10-27
- Decision code
- OK30
- Date received
- 2016-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Abbott Laboratories requests approval to transfer the manufacturing and testing of two monoclonal antibodies from one Abbott manufacturing site to another.