PMA P050049S011
- Device
- AXSYM HBSAG/HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S011
- Product code
- LOM
- Decision date
- 2012-12-05
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
Current openFDA PMA Record#
- Device
- AXSYM HBSAG/HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S011
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-12-05
- Decision code
- OK30
- Date received
- 2012-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.