| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008256118 | 3008256118 | Exact Sciences Corporation- Innovation Campus | 1 | N | 2026-01-01 | 441 Charmany Dr Madison WI US 53719 |
| 3013841562 | 3013841562 | Exact Sciences Corporation- Legacy Campus | 1 | N | 2026-01-01 | 320 Holtzman Road Madison WI US 53713 |
| 3015728010 | 3015728010 | Exact Sciences Corporation- Discovery Campus | 1 | N | 2026-01-01 | 650 Forward Dr Madison WI US 53711 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 232114 | 1875345745 | P230043 | Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™ | PHP | 2024-10-03 |
| 173967 | 1875345745 | P230043 | Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™ | PHP | 2024-10-03 |
| 210404 | 1648519065 | P130017 | COLOGUARD | PHP | 2014-08-11 |
| 232114 | 1648519065 | P130017 | COLOGUARD | PHP | 2014-08-11 |
| 173967 | 1648519065 | P130017 | COLOGUARD | PHP | 2014-08-11 |
| 210404 | 1603620777 | ||||
| 210404 | 1943601418 | ||||
| 210404 | 1950791953 | ||||
| 232114 | 1603620777 | ||||
| 173967 | 1603620777 | ||||
| 173967 | 1872756884 | ||||
| 232114 | 1872756884 | ||||
| 173967 | 1943601418 | ||||
| 232114 | 1943601418 | ||||
| 232114 | 1950791953 | ||||
| 173967 | 1950791953 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PHP | 3 | 2014-08-11 |
Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS054 Date Received07/11/2022 Decision Date08/03/2022 Product Code PHP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Chang...
Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS053 Date Received06/21/2022 Decision Date07/19/2022 Product Code PHP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Chang...
Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS052 Date Received06/08/2022 Decision Date07/07/2022 Product Code PHP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Chang...
Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS051 Date Received03/02/2022 Decision Date04/13/2022 Product Code PHP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling ...
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