PMA P060007S009
- Device
- ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S009
- Product code
- LOM
- Decision date
- 2011-03-30
- Generic name
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Approval order statement
- TEST METHOD CONVERSIONS FOR CALF BOVINE SERUM FOR THE TWO HBSAG ASSAYS.
Current openFDA PMA Record
- Device
- ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
- Applicant
- Abbott Laboratories
- PMA number
- P060007
- Supplement
- S009
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-03-30
- Decision code
- OK30
- Date received
- 2011-03-01
- Supplement type
- 30-Day Notice
- Approval order statement
- TEST METHOD CONVERSIONS FOR CALF BOVINE SERUM FOR THE TWO HBSAG ASSAYS.