DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P020027/S013 · decided 2011-03-11
Approval details
- PMA number
- P020027
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION VISTA 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
- 2010-08-19
- Decision date
- 2011-03-11
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR SOFTWARE CHANGES (VERSION 3.1.1 TO 3.3) AND ASSOCIATED HARDWARE CHANGES TO THE DIMENSION VISTA SYSTEM.
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