DIMENSION FPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P020027/S003 · decided 2005-06-02
Approval details
- PMA number
- P020027
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION FPSA FLEX REAGENT CARTRIDGE
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2005-04-01
- Decision date
- 2005-06-02
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE ADDITION OF THE STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE TO THE DIMENSION RXL MAX.
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