PMA P130017S003
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S003
- Product code
- PHP
- Decision date
- 2015-08-19
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- APPROVAL FOR SEVERAL MINOR MODIFICATIONS TO THE TEST DEFINITIONSOFTWARE FOR COLOGUARD¿.
Current openFDA PMA Record#
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S003
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2015-08-19
- Decision code
- APPR
- Date received
- 2015-06-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SEVERAL MINOR MODIFICATIONS TO THE TEST DEFINITIONSOFTWARE FOR COLOGUARD¿.