Dimension FPSA Flex reagent cartridge (RF451)
FDA premarket approval P020027/S027 · decided 2017-07-17
Approval details
- PMA number
- P020027
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dimension FPSA Flex reagent cartridge (RF451)
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2017-06-20
- Decision date
- 2017-07-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Add the Siemens facility located in Flanders, NJ as an internal supplier for the tested subassembly components for Dimension® EXL system.
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