Dimension FPSA Flex reagent cartridge
FDA premarket approval P020027/S042 · decided 2025-05-22
Approval details
- PMA number
- P020027
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dimension FPSA Flex reagent cartridge
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2025-04-23
- Decision date
- 2025-05-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Transfer of Service Spare Parts Production to Contract Manufacturer.
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