PMA P060012S008
- Device
- AXSYM CORE
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060012
- Supplement
- S008
- Product code
- LOM
- Decision date
- 2011-10-07
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.
Current openFDA PMA Record#
- Device
- AXSYM CORE
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060012
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-10-07
- Decision code
- APPR
- Date received
- 2011-09-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.