ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV
FDA premarket approval P030056/S005 · decided 2009-08-20
Approval details
- PMA number
- P030056
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-03-31
- Decision date
- 2009-08-20
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOT THE ADVIA CENTAUR SYSTEM SOFTWARE VERSION 4.0.
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