- Device
- AXSYM CORE-M 2.0 (LN 3B89)
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060009
- Supplement
- S006
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-12-22
- Decision code
- APPR
- Date received
- 2011-11-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.