PMA P130015S009
- Device
- ELECSYS HBEAG AND PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S009
- Product code
- LOM
- Decision date
- 2017-01-13
- 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
- Approval for the change of proprietary names of Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to Elecsys HBeAg and PreciControl HBeAg.
Current openFDA PMA Record#
- Device
- ELECSYS HBEAG AND PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S009
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-01-13
- Decision code
- APPR
- Date received
- 2016-12-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the change of proprietary names of Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to Elecsys HBeAg and PreciControl HBeAg.