COLOGUARD
FDA premarket approval P130017/S002 · decided 2015-08-18
Approval details
- PMA number
- P130017
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLOGUARD
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2015-05-20
- Decision date
- 2015-08-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE COLOGUARD ASSAY REAGENTS(COLOGUARD MOLECULAR ASSAY REAGENTS, COLOGUARD MOLECULAR CONTROLS, COLOGUARD HEMOGLOBIN ASSAY REAGENTS, AND COLOGUARD HEMOGLOBIN CONTROLS), ON THE BASIS OF ADDITIONAL REAL-TIME STABILITY TESTING, FROM A SHELF-LIFE OF SIX (6) MONTHS TO A SHELF-LIFE OF NINE (9) MONTHS.
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