Atellica IM Prostate-Specific Antigen (PSA) Assay
FDA premarket approval P950021/S024 · decided 2021-04-27
Approval details
- PMA number
- P950021
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Atellica IM Prostate-Specific Antigen (PSA) Assay
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2021-04-01
- Decision date
- 2021-04-27
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Moving manufacturing of Atellica IM analyzers component/subassembly named Autoloader to an internal supplier.
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