PMA P060035S035
- Device
- ARCHITECT CORE-M / Alinity i Anti-HBc IgM
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S035
- Product code
- LOM
- Decision date
- 2022-10-12
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Add an additional supplier for a kit component.
Current openFDA PMA Record#
- Device
- ARCHITECT CORE-M / Alinity i Anti-HBc IgM
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S035
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-10-12
- Decision code
- OK30
- Date received
- 2022-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional supplier for a kit component.