Atellica IM Hepatitis C (aHCV)
FDA premarket approval P030056/S011 · decided 2018-05-09
Approval details
- PMA number
- P030056
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Hepatitis C (aHCV)
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2017-09-29
- Decision date
- 2018-05-09
- Days to decision
- 222 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the migration of the ADVIA Centaur HCV (aHCV) assay and ADVIA Centaur HCV Quality Control Material onto the Atellica IM Analyzer.
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