Atlas FDA

Dako North America, Inc.

9 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
C-Kit pharmDx (P040011/S003)Dako North America, Inc.2017-05-16
PD-L1 IHC NIVOLUMAB PHARMDX (P150027/S004)Dako North America, Inc.2017-03-24
PD-L1 IHC 28-8 PHARMDX (P150027/S003)Dako North America, Inc.2017-02-24
PD-L1 IHC 28-8 PHARMDX (Melanoma Indication) (P150027/S002)Dako North America, Inc.2016-12-01
PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION) (P150027/S001)Dako North America, Inc.2016-10-05
PD-L1 IHC 28-8 pharmDx (P150027)Dako North America, Inc.2016-01-23
C-KIT PHARMDX (P040011/S002)Dako North America, Inc.2012-11-02
DAKO C-KIT PHARMDX (P040011/S001)Dako North America, Inc.2007-04-23
C-KIT PHARMDX (P040011)Dako North America, Inc.2005-06-27

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Every clearance here is in the API, with alerts when new ones post.