- Device
- Atellica® IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S018
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2021-11-09
- Decision code
- APPR
- Date received
- 2021-08-11
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an extension to the on-board stability claim for the assay on the Atellica IM analyzer.