PMA P130017S006
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S006
- Product code
- PHP
- Decision date
- 2016-02-04
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Change in test methodology for one of the incoming materials used in the Cologuard® sDNA based colorectal cancer screening test.
Current openFDA PMA Record#
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S006
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2016-02-04
- Decision code
- OK30
- Date received
- 2016-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in test methodology for one of the incoming materials used in the Cologuard® sDNA based colorectal cancer screening test.