PMA P980041S010
- Device
- IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S010
- Product code
- LOK
- Decision date
- 2007-11-27
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR CHANGING THE SURFACTANT USED IN THE WASH BUFFER.
Current openFDA PMA Record#
- Device
- IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S010
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2007-11-27
- Decision code
- APPR
- Date received
- 2007-09-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE SURFACTANT USED IN THE WASH BUFFER.