DIMENSION FPSA FLEX REAGENT CARTRIDGE (RF452)
FDA premarket approval P020027/S024 · decided 2016-08-30
Approval details
- PMA number
- P020027
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIMENSION FPSA FLEX REAGENT CARTRIDGE (RF452)
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2016-08-03
- Decision date
- 2016-08-30
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Add a filtration step in the Chrome Particle Raw Material (CPRM) manufacturing process.
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