PMA P980041S036
- Device
- Access AFP Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S036
- Product code
- LOK
- Decision date
- 2017-06-16
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval for a modification to the UniCel Dxl Clinical System's sample probe to improve the manufacturability of the component.
Current openFDA PMA Record#
- Device
- Access AFP Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S036
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2017-06-16
- Decision code
- APPR
- Date received
- 2017-03-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the UniCel Dxl Clinical System's sample probe to improve the manufacturability of the component.