Approval for modifications to the formulation of the her2 fish pharmdx kit. The device, as modified, will be marketed under the trade name her2 iqfish pharmdx.
| Device | HER2 IQFISH PHARMDX |
| Classification Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Generic Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2011-12-14 |
| Decision Date | 2012-12-05 |
| PMA | P040005 |
| Supplement | S007 |
| Product Code | MVD |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040005 | | Original Filing |
| S014 |
2017-03-13 |
30-day Notice |
| S013 |
2016-03-16 |
30-day Notice |
| S012 |
2016-01-08 |
30-day Notice |
| S011 |
2015-08-13 |
30-day Notice |
| S010 |
2013-08-01 |
30-day Notice |
| S009 |
2012-08-24 |
Normal 180 Day Track |
| S008 |
2012-07-11 |
30-day Notice |
| S007 |
2011-12-14 |
Normal 180 Day Track |
| S006 |
2011-12-05 |
Normal 180 Day Track |
| S005 |
2010-04-20 |
Panel Track |
| S004 |
2010-03-10 |
135 Review Track For 30-day Notice |
| S003 |
2008-07-10 |
Real-time Process |
| S002 |
2007-10-29 |
Real-time Process |
| S001 |
2005-08-15 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices