PMA P930036S008
- Device
- Atellica IM Alpha Fetoprotein (AFP)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S008
- Product code
- LOK
- Decision date
- 2018-05-04
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval for the migration of the ADVIA Centaur AFP Assay to the Atellica IM Analyzer.
Current openFDA PMA Record#
- Device
- Atellica IM Alpha Fetoprotein (AFP)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S008
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2018-05-04
- Decision code
- APPR
- Date received
- 2017-09-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the ADVIA Centaur AFP Assay to the Atellica IM Analyzer.