PMA P060003S009
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S009
- Product code
- LOM
- Decision date
- 2011-05-13
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE QUALITY CONTROL TEST METHODS.
Current openFDA PMA Record#
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S009
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-05-13
- Decision code
- APPR
- Date received
- 2011-03-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE QUALITY CONTROL TEST METHODS.