PMA P980041S051
- Device
- Access AFP (on DxI 9000 Analyzer)
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S051
- Product code
- LOK
- Decision date
- 2025-11-03
- Classification
- Immunology
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- migration of the Access AFP to the DxI 9000 Access Immunoassay Analyzer.
Current openFDA PMA Record#
- Device
- Access AFP (on DxI 9000 Analyzer)
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S051
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2025-11-03
- Decision code
- APPR
- Date received
- 2024-10-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- migration of the Access AFP to the DxI 9000 Access Immunoassay Analyzer.