Elecsys HBsAg II
FDA premarket approval P160019/S006 · decided 2017-12-20
Approval details
- PMA number
- P160019
- Supplement
- S006
- 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
- 2017-10-11
- Decision date
- 2017-12-20
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for implementation of system software 06-04 on the cobas e 602 to address a software limitation
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