PMA P050051S011
- Device
- ARCHITECT AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S011
- Product code
- LOM
- Decision date
- 2011-05-13
- 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 TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.
Current openFDA PMA Record#
- Device
- ARCHITECT AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S011
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-05-13
- Decision code
- OK30
- Date received
- 2011-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.