Approval to market the herceptest kit for automated link platforms and the changes involved in the assay procedure to use the new instrument, change in the qc procedure with reference to chromogen, changes in the criteria regarding the control tissue during qc and changes in the specimen preparation.
| Device | HERCEP TEST |
| Classification Name | System, Test, Her-2/neu, Ihc |
| Generic Name | System, Test, Her-2/neu, Ihc |
| Applicant | DAKO A/S |
| Date Received | 2008-05-28 |
| Decision Date | 2010-02-25 |
| PMA | P980018 |
| Supplement | S006 |
| Product Code | MVC |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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