This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Addition of a distribution site.
| Device | PD-L1 IHC 28-8 pharmDx |
| Classification Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2019-02-15 |
| Decision Date | 2019-03-13 |
| PMA | P150025 |
| Supplement | S011 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150025 | Original Filing | |
| S015 | 2022-06-17 | 30-day Notice |
| S014 | 2021-07-12 | Normal 180 Day Track |
| S013 | 2019-12-16 | Panel Track |
| S012 | ||
| S011 | 2019-02-15 | 30-day Notice |
| S010 | 2018-12-21 | 30-day Notice |
| S009 | 2018-03-12 | 30-day Notice |
| S008 | 2017-12-26 | 30-day Notice |
| S007 | ||
| S006 | 2017-04-17 | 30-day Notice |
| S005 | 2016-12-29 | Normal 180 Day Track No User Fee |
| S004 | 2016-12-27 | Real-time Process |
| S003 | 2016-12-22 | Panel Track |
| S002 | 2016-08-19 | Real-time Process |
| S001 | 2016-07-07 | Real-time Process |