PMA P050051S036
- Device
- ARCHITECT AUSAB, LN 1L82
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S036
- Product code
- LOM
- Decision date
- 2019-12-03
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Change the upstream testing criteria for a critical material used in kit components.
Current openFDA PMA Record#
- Device
- ARCHITECT AUSAB, LN 1L82
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S036
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2019-12-03
- Decision code
- OK30
- Date received
- 2019-11-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the upstream testing criteria for a critical material used in kit components.