DIMENSION TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S010 · decided 2007-09-14
Approval details
- PMA number
- P000021
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2007-08-14
- Decision date
- 2007-09-14
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION EXL CLINICAL CHEMISTRY SYSTEM.
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