PMA P060003S002
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S002
- Product code
- LOM
- Decision date
- 2006-10-04
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- IMPLEMENTATION OF ADDITIONAL IN-PROCESS TESTING.
Current openFDA PMA Record#
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S002
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2006-10-04
- Decision code
- OK30
- Date received
- 2006-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF ADDITIONAL IN-PROCESS TESTING.