PMA P010007
- Device
- IMMULITE Systems AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S017
- Product code
- LOK
- Decision date
- 2026-09-22
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- to move manufacturing of a critical component within the same facility
Current openFDA PMA Record#
- Device
- IMMULITE Systems AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S028
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2026-09-22
- Decision code
- OK30
- Date received
- 2026-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to move manufacturing of a critical component within the same facility