PMA P060035S036
- Device
- Alinity i Anti-HBc IgM (List Number 07P86)
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S036
- Product code
- LOM
- Decision date
- 2022-10-25
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Addition of a new fill line in existing manufacturing space.
Current openFDA PMA Record#
- Device
- Alinity i Anti-HBc IgM (List Number 07P86)
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S036
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-10-25
- Decision code
- OK30
- Date received
- 2022-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new fill line in existing manufacturing space.