PMA P060007S006
- Device
- ARCHITECT HBSAG/CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S006
- Product code
- LOM
- Decision date
- 2011-01-14
- Generic name
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
Current openFDA PMA Record
- Device
- ARCHITECT HBSAG/CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S006
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-01-14
- Decision code
- APPR
- Date received
- 2010-12-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.