PMA P110029S041
- Device
- ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S041
- Decision date
- 2023-01-30
- Approval order statement
- Switch to a new supplier of a noncritical manufacturing ingredient.
Current openFDA PMA Record#
- Device
- ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S041
- Decision date
- 2023-01-30
- Decision code
- OK30
- Date received
- 2023-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Switch to a new supplier of a noncritical manufacturing ingredient.