This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Modification of the quality control for incoming alu-pnas materials toreduce high background signal in the negative controls.
| Device | HER2 CISH PHARMDX KIT |
| Generic Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2014-12-03 |
| Decision Date | 2014-12-29 |
| PMA | P100024 |
| Supplement | S006 |
| Product Code | NYQ |
| 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 DENMARK A/S 42 Produktionsvej dk-2600 glostrup DK-26-2600 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100024 | Original Filing | |
| S013 | 2017-03-13 | 30-day Notice |
| S012 | 2017-03-13 | 30-day Notice |
| S011 | 2016-12-27 | Real-time Process |
| S010 | 2016-07-01 | Real-time Process |
| S009 | 2016-03-16 | 30-day Notice |
| S008 | 2016-01-08 | 30-day Notice |
| S007 | 2015-08-13 | 30-day Notice |
| S006 | 2014-12-03 | 30-day Notice |
| S005 | 2013-08-01 | 30-day Notice |
| S004 | 2012-11-16 | Normal 180 Day Track |
| S003 | 2012-09-20 | Real-time Process |
| S002 | 2012-07-11 | 30-day Notice |
| S001 | 2011-12-07 | Real-time Process |