PMA P980041S048
- Device
- Access AFP Reagents on the Access Immunoassay System
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S048
- Product code
- LOK
- Decision date
- 2020-10-16
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval for a change to implement a new resin blend for the UniCel DxI Wash Buffer II Cubitainer.
Current openFDA PMA Record#
- Device
- Access AFP Reagents on the Access Immunoassay System
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S048
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2020-10-16
- Decision code
- APPR
- Date received
- 2020-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to implement a new resin blend for the UniCel DxI Wash Buffer II Cubitainer.