ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBC IGM
FDA premarket approval P030040/S006 · decided 2009-08-19
Approval details
- PMA number
- P030040
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBC IGM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-05-18
- Decision date
- 2009-08-19
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADVIA CENTAUR XP SYSTEM SOFTWARE VERSION 6.0.
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