Atellica IM CPSA Assay
FDA premarket approval P990055/S016 · decided 2018-08-03
Approval details
- PMA number
- P990055
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM CPSA Assay
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2017-09-29
- Decision date
- 2018-08-03
- Days to decision
- 308 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the migration of the ADVIA Centaur cPSA assay to the Atellica IM system
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