Approval for the dako herceptest. This device is a semi-quantitative immunohistochemical assay to determine her2 overexpression in breast cancer tissues routinely processed for histological evaluation. Herceptest is indicated as an aid in the assessment of patients for whom herceptin(r)(transtuzumab) treatment is being considered.
| Device | DAKO HERCEPTEST |
| Classification Name | System, Test, Her-2/neu, Ihc |
| Generic Name | System, Test, Her-2/neu, Ihc |
| Applicant | DAKO A/S |
| Date Received | 1998-05-18 |
| Decision Date | 1998-09-25 |
| Notice Date | 1998-10-27 |
| PMA | P980018 |
| Supplement | S |
| Product Code | MVC |
| Docket Number | 98M-0857 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO A/S 42 Produktionsvej glostrup DK-26-2600 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980018 | | Original Filing |
| S025 |
2020-06-04 |
30-day Notice |
| S024 |
2018-01-12 |
30-day Notice |
| S023 |
2016-12-27 |
Real-time Process |
| S022 |
2016-06-06 |
Real-time Process |
| S021 |
2016-02-29 |
Real-time Process |
| S020 |
2015-08-13 |
30-day Notice |
| S019 |
2015-04-27 |
30-day Notice |
| S018 |
2013-11-21 |
Special (immediate Track) |
| S017 |
2012-11-01 |
Normal 180 Day Track |
| S016 |
2012-08-24 |
Normal 180 Day Track |
| S015 |
2011-12-05 |
Normal 180 Day Track |
| S014 |
2011-08-15 |
30-day Notice |
| S013 |
2011-04-06 |
Special (immediate Track) |
| S012 |
2011-01-24 |
30-day Notice |
| S011 |
2010-09-09 |
Normal 180 Day Track |
| S010 |
2010-04-21 |
Panel Track |
| S009 |
2010-02-25 |
Real-time Process |
| S008 |
2010-02-12 |
30-day Notice |
| S007 |
2009-12-31 |
30-day Notice |
| S006 |
2008-05-28 |
Normal 180 Day Track |
| S005 |
2005-12-08 |
Special (immediate Track) |
| S004 |
2005-06-20 |
30-day Notice |
| S003 |
2004-11-10 |
Normal 180 Day Track No User Fee |
| S002 |
2003-05-14 |
30-day Notice |
| S001 |
2002-11-15 |
Real-time Process |
NIH GUDID Devices