DIMENSION TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S004 · decided 2004-12-02
Approval details
- PMA number
- P000021
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2004-11-15
- Decision date
- 2004-12-02
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION XPAND PLUS ANALYZER.
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