PMA P980041S009
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S009
- Product code
- LOK
- Decision date
- 2007-09-12
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR THE USE OF THE ACCESS AFP REAGENTS ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM.
Current openFDA PMA Record#
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S009
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2007-09-12
- Decision code
- APPR
- Date received
- 2007-05-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF THE ACCESS AFP REAGENTS ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM.