Changed manufacturing process (order of addition) of components in two diluent solutions.
| Device | PD L1 IHC 22C3 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 | 2017-12-26 |
| Decision Date | 2018-01-22 |
| PMA | P150013 |
| Supplement | S008 |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150013 | | Original Filing |
| S025 |
2022-08-08 |
Real-time Process |
| S024 |
2022-01-31 |
Special (immediate Track) |
| S023 |
2021-11-17 |
Special (immediate Track) |
| S022 | | |
| S021 |
2020-08-31 |
Normal 180 Day Track |
| S020 |
2020-06-29 |
Panel Track |
| S019 |
2020-02-06 |
Normal 180 Day Track No User Fee |
| S018 |
2019-09-05 |
Normal 180 Day Track No User Fee |
| S017 |
2019-06-14 |
Normal 180 Day Track |
| S016 |
2019-02-25 |
Panel Track |
| S015 |
2019-02-15 |
30-day Notice |
| S014 | | |
| S013 |
2018-12-21 |
30-day Notice |
| S012 | | |
| S011 |
2018-06-25 |
Panel Track |
| S010 |
2018-03-12 |
30-day Notice |
| S009 |
2018-01-29 |
Panel Track |
| S008 |
2017-12-26 |
30-day Notice |
| S007 |
2017-09-21 |
Normal 180 Day Track No User Fee |
| S006 |
2017-04-19 |
Panel Track |
| S005 |
2017-04-17 |
30-day Notice |
| S004 |
2016-12-27 |
Real-time Process |
| S003 |
2016-08-19 |
Real-time Process |
| S002 |
2016-06-28 |
Real-time Process |
| S001 |
2015-12-31 |
Panel Track |
NIH GUDID Devices