PMA P050049S010
- Device
- AXSYM HBSAG
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S010
- Product code
- LOM
- Decision date
- 2012-03-01
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGE TO THE TWO MICROBIAL TESTING METHODS FOR BIOBURDEN AND STERILITY DETERMINATION FOR CODE 37199 AND 97218.
Current openFDA PMA Record#
- Device
- AXSYM HBSAG
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S010
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-03-01
- Decision code
- OK30
- Date received
- 2012-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE TWO MICROBIAL TESTING METHODS FOR BIOBURDEN AND STERILITY DETERMINATION FOR CODE 37199 AND 97218.