PMA P110029S022
- Device
- ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54)
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S022
- Product code
- LOM
- Decision date
- 2015-08-13
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
Current openFDA PMA Record#
- Device
- ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54)
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S022
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2015-08-13
- Decision code
- OK30
- Date received
- 2015-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.