Dako North America Inc.
6 FDA 510(k) clearances · Recalling firm
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| Record | Firm | Date |
|---|---|---|
| EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High p recall (Z-0220-2016) | Dako North America Inc. | 2015-11-05 |
| Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis S recall (Z-1548-2015) | Dako North America Inc. | 2015-04-29 |
| Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400) recall (Z-1261-2015) | Dako North America Inc. | 2015-03-16 |
| Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Us recall (Z-2708-2014) | Dako North America Inc. | 2014-09-26 |
| Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usag recall (Z-1093-2014) | Dako North America Inc. | 2014-02-26 |
| PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarize recall (Z-0287-2013) | Dako North America Inc. | 2012-11-13 |
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Every clearance here is in the API, with alerts when new ones post.