Company ยท US
Dako North America Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2016. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPA | Slide Stainer, Automated | 3 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 2 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 2 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | 2 |
| IDY | Bath, Flotation, Tissue | 1 |
| LDT | 1 | |
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 2016 | K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Dako North America, Inc. | MXZ |
| Dec 9, 2013 | K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) Dako North America, Inc. | MXZ |
| Feb 12, 2013 | K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI Dako North America, Inc. | MYA |
| May 8, 2009 | K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 Dako North America, Inc. | MYA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2018 | Dako North America Inc. PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options. Terminated |
PLS | None listed |
| Jun 10, 2016 | Dako North America Inc. Dako HER2 CISH pharmDx Kit, product code: SK 109
Product Usage:
For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directl Terminated |
NYQ | None listed |
| Nov 5, 2015 | Dako North America Inc. EnVision FLEX/HRP visualization reagent found in the following kits:
EnVision FLEX, High pH (Link)
EnVision FLEX+, Mouse, High pH (Link)
EnVision FLEX Mini Kit, High pH (Link)
EnVision FLEX, High pH ( Terminated |
LDT | None listed |
| Apr 29, 2015 | Dako North America Inc. Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use.
The TRD is intended to distribute patient Terminated |
KPA | None listed |
| Mar 16, 2015 | Dako North America Inc. Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use. Terminated |
KPA | None listed |
| Sep 26, 2014 | Dako North America Inc. Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480
Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compa Terminated |
KPA | None listed |
| Feb 26, 2014 | Dako North America Inc. Product Name: HER2 CISH pharmDx Kit
Catalog/Model number: SK109, lot 20000910
Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization o Terminated |
NYQ | None listed |
| Nov 13, 2012 | Dako North America Inc. PT Link Waterbath, Model#PT100.
Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. Terminated |
IDY | None listed |