PMA P060007S017
- Device
- ABBOTT ARCHITECT HBSAG & HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S017
- Product code
- LOM
- Decision date
- 2012-01-13
- Generic name
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Approval order statement
- CHANGE TO A QUALITY CONTROL TEST METHOD USED FOR BIOBURDEN EVALUATION.
Current openFDA PMA Record
- Device
- ABBOTT ARCHITECT HBSAG & HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S017
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-01-13
- Decision code
- OK30
- Date received
- 2011-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO A QUALITY CONTROL TEST METHOD USED FOR BIOBURDEN EVALUATION.