PMA P060003S001
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S001
- Product code
- LOM
- Decision date
- 2006-09-11
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- IMPLEMENTATION OF ADDITIONAL TESTING AT TWO DIFFERENT STAGES IN THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- ABBOTT AXSYM AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060003
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2006-09-11
- Decision code
- OK30
- Date received
- 2006-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF ADDITIONAL TESTING AT TWO DIFFERENT STAGES IN THE MANUFACTURING PROCESS.