PMA P160019S005
- Device
- Elecsys HBsAg II
- Applicant
- Roche Diagnostics, Inc.
- PMA number
- P160019
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2017-08-31
- 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
- Install an additional bead coating apparatus.
Current openFDA PMA Record#
- Device
- Elecsys HBsAg II
- Applicant
- Roche Diagnostics, Inc.
- PMA number
- P160019
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-08-31
- Decision code
- OK30
- Date received
- 2017-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Install an additional bead coating apparatus.