PMA P120008S002
- Device
- ARCHITECT AFP ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S002
- Product code
- LOK
- Decision date
- 2013-08-27
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR MIGRATION OF ARCHITECT AFP ASSAY TO THE ARCHITECT ISYSTEM FAMILY MEMBER, THE ARCHITECT IL000SR.
Current openFDA PMA Record#
- Device
- ARCHITECT AFP ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S002
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2013-08-27
- Decision code
- APPR
- Date received
- 2013-02-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MIGRATION OF ARCHITECT AFP ASSAY TO THE ARCHITECT ISYSTEM FAMILY MEMBER, THE ARCHITECT IL000SR.