PMA P060012S004
- Device
- AXSYM CORE 2.0 (LN 8B88)
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060012
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2010-10-19
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- MODIFICATIONS TO THE COMMON ACCESSORY FOR AXSYM HEPATITIS PRODUCTS.
Current openFDA PMA Record#
- Device
- AXSYM CORE 2.0 (LN 8B88)
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P060012
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2010-10-19
- Decision code
- OK30
- Date received
- 2010-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATIONS TO THE COMMON ACCESSORY FOR AXSYM HEPATITIS PRODUCTS.