PMA P980041S039
- Device
- Access AFP Immunoassay
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S039
- Product code
- LOK
- Decision date
- 2017-10-24
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.
Current openFDA PMA Record#
- Device
- Access AFP Immunoassay
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S039
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2017-10-24
- Decision code
- OK30
- Date received
- 2017-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.