PMA P010007S024
- Device
- IMMULITE 2000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S024
- Product code
- LOK
- Decision date
- 2025-10-30
- Classification
- Immunology
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval for the move of critical raw material operations of an internal supplier in-house to an internal company site.
Current openFDA PMA Record#
- Device
- IMMULITE 2000 AFP
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P010007
- Supplement
- S024
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2025-10-30
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the move of critical raw material operations of an internal supplier in-house to an internal company site.