Change in the manufacturing filling process to increase the reagent fill volume to address shortage concerns.
| Device | HERCEPTEST |
| Classification Name | System, Test, Her-2/neu, Ihc |
| Generic Name | System, Test, Her-2/neu, Ihc |
| Applicant | DAKO A/S |
| Date Received | 2010-02-12 |
| Decision Date | 2010-03-08 |
| PMA | P980018 |
| Supplement | S008 |
| Product Code | MVC |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| 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