Addition of alternate suppliers of key reagents for the test system.
| Device | Epi proColon |
| Classification Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Generic Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Applicant | EPIGENOMICS AG |
| Date Received | 2018-02-20 |
| Decision Date | 2018-03-20 |
| PMA | P130001 |
| Supplement | S004 |
| Product Code | PHP |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EPIGENOMICS AG geneststr.5 berlin |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130001 | | Original Filing |
| S007 |
2021-06-21 |
Real-time Process |
| S006 | | |
| S005 |
2019-08-06 |
30-day Notice |
| S004 |
2018-02-20 |
30-day Notice |
| S003 | | |
| S002 |
2016-05-10 |
Normal 180 Day Track No User Fee |
| S001 |
2016-04-29 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices