PMA P980041S046
- Device
- Access AFP Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S046
- Product code
- LOK
- Decision date
- 2020-03-17
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval for modification to the UniCel DxI Immunoassay Systems pick and place gantries.
Current openFDA PMA Record#
- Device
- Access AFP Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S046
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2020-03-17
- Decision code
- APPR
- Date received
- 2019-12-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification to the UniCel DxI Immunoassay Systems pick and place gantries.