PMA P130001S002
- Device
- Epi proColon
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S002
- Product code
- PHP
- Decision date
- 2016-10-18
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Approval of the post-approval study protocol.
Current openFDA PMA Record#
- Device
- Epi proColon
- Applicant
- New Day Diagnostics, LLC
- PMA number
- P130001
- Supplement
- S002
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2016-10-18
- Decision code
- APPR
- Date received
- 2016-05-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the post-approval study protocol.