PMA P130015S017
- Device
- Elecsys HBeAg Test System
- Applicant
- Roche Diagnostics Operations, Inc.
- Decision date
- 2023-04-18
- Approval order statement
- Approval for the migration of the Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to the cobas e 402 immunoassay analyzer
Current openFDA PMA Record
- Device
- Elecsys HBeAg Test System
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S017
- Decision date
- 2023-04-18
- Decision code
- APPR
- Date received
- 2022-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to the cobas e 402 immunoassay analyzer