PMA P110029S019
- Device
- ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S019
- Product code
- LOM
- Decision date
- 2014-12-17
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- SCALE UP THE MANUFACTURING BATCH SIZE FOR THE MICROPARTICLE CONCENTRATES.
Current openFDA PMA Record#
- Device
- ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S019
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2014-12-17
- Decision code
- OK30
- Date received
- 2014-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SCALE UP THE MANUFACTURING BATCH SIZE FOR THE MICROPARTICLE CONCENTRATES.