- Device
- Atellica IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S016
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2021-04-27
- Decision code
- OK30
- Date received
- 2021-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving manufacturing of Atellica IM analyzer’s component/subassembly named Autoloader to an internal supplier.