PMA P930036S019
- Device
- Atellica® IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S019
- Product code
- LOK
- Decision date
- 2022-03-29
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Manufacture an instrument component at another location.
Current openFDA PMA Record#
- Device
- Atellica® IM Alpha Fetoprotein (AFP) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S019
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2022-03-29
- Decision code
- OK30
- Date received
- 2022-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture an instrument component at another location.