Dako North America Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2425-2018 | Class II | PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of | February 2, 2018 |
| Z-2099-2016 | Class II | Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER | June 10, 2016 |
| Z-0220-2016 | Class II | EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) | September 4, 2015 |
| Z-1548-2015 | Class II | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an | April 1, 2015 |
| Z-1261-2015 | Class II | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Auto | February 12, 2015 |
| Z-2708-2014 | Class II | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: F | August 29, 2014 |
| Z-1093-2014 | Class II | Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: Fo | January 21, 2014 |
| Z-0287-2013 | Class II | PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alter | May 1, 2008 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclo | May 3, 2016 |
| K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | December 9, 2013 |
| K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | February 12, 2013 |
| K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | May 8, 2009 |