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.
Add an alternate supplier of texas red labeled dctp nucleotide and to replace an in-process qc procedure with a new qc test on ffpe breast cancer tissue.
| Device | TOP2A FISH PHARMDX KIT |
| Generic Name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2011-10-06 |
| Decision Date | 2011-11-10 |
| PMA | P050045 |
| Supplement | S003 |
| Product Code | NXG |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050045 | Original Filing | |
| S004 | 2011-12-23 | 135 Review Track For 30-day Notice |
| S003 | 2011-10-06 | 30-day Notice |
| S002 | 2008-03-06 | 30-day Notice |
| S001 | 2008-01-28 | Real-time Process |