DIMENSION TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S003 · decided 2003-12-30
Approval details
- PMA number
- P000021
- Supplement
- S003
- 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
- 2003-12-17
- Decision date
- 2003-12-30
- Days to decision
- 13 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 RXL MAX ANALYZER. THE DEVICE WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR: THE TPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DR
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