DIMENSION FPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P020027/S014 · decided 2010-12-13
Approval details
- PMA number
- P020027
- Supplement
- S014
- Supplement type
- Real-Time Process
- 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
- 2010-10-18
- Decision date
- 2010-12-13
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL TO REMOVE THE REAGENT MANAGEMENT SYSTEM FROM THE DIMENSION EXL WITH LM SYSTEM. THE CONFIGURATION WILL BE CALLED THE DIMENSION EXL 200 SYSTEM.
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