Elecsys HBsAg II
FDA premarket approval P160019/S007 · decided 2018-06-13
Approval details
- PMA number
- P160019
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Elecsys HBsAg II
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics, Inc.
- Date received
- 2018-04-17
- Decision date
- 2018-06-13
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series
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