FPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P020027/S009 · decided 2010-05-17
Approval details
- PMA number
- P020027
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- 2008-12-02
- Decision date
- 2010-05-17
- Days to decision
- 531 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES:1) DETECTION TECHNOLOGY FROM SPECTROPHOTOMETRY TO CHEMILUMINESENCE;2) APPROPRIATE REAGENT PROCESS CHANGES TO ACCOMMODATE CHEMILUMINESENCE DETECTION;3) USAGE ON THE DIMENSION VISTA 1500 SYSTEM;4) USAGE ON THE DIMENSION VISTA 3000T SYSTEM WHICH CONSISTS OF TWO DIMENSION VISTA1500 SYSTEMS CONNECTED BY A SAMPLE TRACK TRANSPORT MECHANISM; AND5) USAGE ON THE DIMENSION VISTA 1500 SYSTEM CONNECTED TO THE STREAMLAB ANALYTICALWORKCELL LABORATORY AUTOMATION SYSTEM.THE DEV
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