DAKO NORTH AMERICA, INC

FDA Filings

This page includes the latest FDA filings for DAKO NORTH AMERICA, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Dako North America, Inc.
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor A, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)2016-05-03
DAKO NORTH AMERICA, INC.
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)2013-12-09
DAKO NORTH AMERICA, INC.
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI2013-02-12

Latest Premarket Applications

PMAManufacturerDevice NameDate
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2020-03-19
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PharmDx2020-02-27
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2019-07-30
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx2019-03-13
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PharmDx2019-03-13
DAKO NORTH AMERICA, INC.
EGFR pharmDx2019-03-13
DAKO NORTH AMERICA, INC.
EGFR pharmDx2019-01-17
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx2019-01-17
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2019-01-17
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2018-08-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2018-06-12
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PharmDx2018-04-10
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx2018-04-10
DAKO NORTH AMERICA, INC.
EGFR pharmDx2018-04-10
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx2018-01-22
DAKO NORTH AMERICA, INC.
EGFR pharmDx2018-01-22
DAKO NORTH AMERICA, INC.
PD L1 IHC 22C3 pharmDx2018-01-22
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2017-11-20
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2017-09-22
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX2017-09-15
DAKO NORTH AMERICA, INC.
C-Kit pharmDx2017-05-16
DAKO NORTH AMERICA, INC.
EGFR pharmDx2017-05-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx2017-05-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx2017-05-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx2017-05-03
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PHARMDX2017-03-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC NIVOLUMAB PHARMDX2017-03-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC NIVOLUMAB PHARMDX2017-03-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX2017-02-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PHARMDX2016-12-01

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
EGFR pharmDx™ for Autostainer
Dako North America, Inc.2019-10-21
EGFR pharmDx™
Dako North America, Inc.2019-10-21
PD-L1 IHC 22C3 pharmDx
Dako North America, Inc.2019-06-24
FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link)
Dako North America, Inc.2019-06-24
Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294
Dako North America, Inc.2019-06-24
Dako ER/PR pharmDx Kit (Link)
Dako North America, Inc.2019-06-24
Dako ER/PR pharmDx Kit For the Dako Autostainer
Dako North America, Inc.2019-06-24
Mono Mo A-Hu Progesterone Receptor, Cl PgR 636
Dako North America, Inc.2019-06-24
Mono Mo A-Hu Progesterone Receptor, Cl PgR 636
Dako North America, Inc.2019-06-24
FLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link)
Dako North America, Inc.2019-06-24
Dako
Dako North America, Inc.2018-09-21
Dako
Dako North America, Inc.2018-07-06
Dako
Dako North America, Inc.2018-07-06
PD-L1 IHC 28-8 pharmDx
Dako North America, Inc.2018-03-29

Related Finance Registrations

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