COLOGUARD
FDA premarket approval P130017/S003 · decided 2015-08-19
Approval details
- PMA number
- P130017
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COLOGUARD
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2015-06-04
- Decision date
- 2015-08-19
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- APPROVAL FOR SEVERAL MINOR MODIFICATIONS TO THE TEST DEFINITIONSOFTWARE FOR COLOGUARD¿.
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