- Device
- Advia Centaur AFP Immunoassay and Atellica IM AFP Immunoassay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S012
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2020-07-02
- Decision code
- APPR
- Date received
- 2019-09-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a new model luminometer utilized in the in-process testing of Lite Reagent components.