PMA P130015S014
- Device
- Elecsys HBeAg
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S014
- Product code
- LOM
- Decision date
- 2017-12-20
- 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
- Approval for implementation of system software 06-04 on the cobas e 602 to address a software limitation
Current openFDA PMA Record#
- Device
- Elecsys HBeAg
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S014
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-12-20
- Decision code
- APPR
- Date received
- 2017-10-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for implementation of system software 06-04 on the cobas e 602 to address a software limitation