Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay
FDA premarket approval P990055/S019 · decided 2020-07-02
Approval details
- PMA number
- P990055
- Supplement
- S019
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2019-09-19
- Decision date
- 2020-07-02
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the implementation of a new model luminometer utilized in the in-process testing of Lite Reagent components.
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