DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S013 · decided 2010-05-19
Approval details
- PMA number
- P000021
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2008-12-02
- Decision date
- 2010-05-19
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES:1) DETECTION TECHNOLOGY FROM SPECTROPHOTOMETRY TO CHEMILUMINESENCE2) APPROPRIATE REAGENT PROCESS CHANGES TO ACCOMMODATE CHEMILUMINESENCE DETECTION3) USAGE ON THE DIMENSION VISTA 1500 SYSTEM4) USAGE ON THE DIMENSION VISTA 3000T SYSTEM WHICH CONSISTS OF TWO DIMENSION VISTA1500 SYSTEMS CONNECTED BY A SAMPLE TRACK TRANSPORT MECHANISM5) USAGE ON THE DIMENSION VISTA 1500 SYSTEM CONNECTED TO THE STREAMLAB ANALYTICALWORKCELL LABORATORY AUTOMATION SYSTEM6) THE NEW DIMEN
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