PMA P200013S012
- Device
- Alinity m HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S012
- Decision date
- 2023-01-13
- Approval order statement
- Supplier site relocation with process changes for a critical component.
Current openFDA PMA Record#
- Device
- Alinity m HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S012
- Decision date
- 2023-01-13
- Decision code
- OK30
- Date received
- 2022-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier site relocation with process changes for a critical component.