DAKO NORTH AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2022180	2022180	DAKO NORTH AMERICA, INC.	1	Y	2020-04-25	6392 VIA REAL CARPINTERIA CA US 93013

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
05700571105368	Fragile X Fluorescein-Labelled Probe - Y1442	+1-805-566-6655	dako.usregulatory@agilent.com
05700571112465	User-Fillable Reagent Bottle 5mL Capacity (Link) - SK200	+1-805-566-6655	dako.usregulatory@agilent.com

agilent.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
13220	1899769849	P150025	PD-L1 IHC 28-8 pharmDx		2015-10-09
13220	2020266277	P150013	PD-L1 IHC 22C3 PHARMDX	PLS	2015-10-02
13220	1624158755	P030044	DAKOCYTOMATION EGFR PHARMDX	NQF	2004-02-12
13220	1111735081	K984188	AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)	JOY	1999-07-28
13220	1158874605	K170028	FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)	MYA	2017-12-21
13220	1386555872	K170005	FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)	MXZ	2017-12-21
13220	1402099505	K130861	MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)	MXZ	2013-12-09
13220	1349533719	K120663	MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI	MYA	2013-02-12
13220	1618722967	K042884	DAKOCYTOMATION ER/PR PHARMDX KIT	MXZ	2005-02-15
13220	1411526028	K032113	ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)	NOT	2003-12-23
13220	1658671774	K020023	DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING	MXZ	2002-02-28
13220	1033313466
13220	1067474226
13220	1068501444
13220	1130233038
13220	1210967490
13220	1249787114
13220	1287783166
13220	1359362217
13220	1371057551
13220	1377051165
13220	1413581631
13220	1433066984
13220	1451403817
13220	1456624308
13220	1467628315
13220	1470112281
13220	1521122269
13220	1540008035
13220	1552932253
13220	1599811939
13220	1644422591
13220	1714376086
13220	1734240456
13220	1757690793
13220	1765068120
13220	1826540424
13220	1894018312
13220	1953278865
13220	1958152101
13220	2003502626
13220	2018555278

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MXZ	4	2017-12-21
MYA	2	2017-12-21
PLS	2	2015-10-09
NQF	1	2004-02-12
NOT	1	2003-12-23
JOY	1	1999-07-28

PMA#

PD-L1 IHC 22C3 pharmDX
2020-11-13
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PharmDx
2020-11-06
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2020-05-15
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2020-03-19
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PharmDx
2020-02-27
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2019-07-30
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2019-03-13
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PharmDx
2019-03-13
DAKO NORTH AMERICA, INC.
EGFR pharmDx
2019-03-13
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2019-01-17
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2019-01-17
DAKO NORTH AMERICA, INC.
EGFR pharmDx
2019-01-17
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2018-08-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2018-06-12
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2018-04-10
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PharmDx
2018-04-10
DAKO NORTH AMERICA, INC.
EGFR pharmDx
2018-04-10
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2018-01-22
DAKO NORTH AMERICA, INC.
EGFR pharmDx
2018-01-22
DAKO NORTH AMERICA, INC.
PD L1 IHC 22C3 pharmDx
2018-01-22
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2017-11-20
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2017-09-22
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX
2017-09-15
DAKO NORTH AMERICA, INC.
C-Kit pharmDx
2017-05-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2017-05-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 pharmDx
2017-05-16
DAKO NORTH AMERICA, INC.
EGFR pharmDx
2017-05-16
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2017-05-03
DAKO NORTH AMERICA, INC.
PD-L1 IHC NIVOLUMAB PHARMDX
2017-03-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC NIVOLUMAB PHARMDX
2017-03-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PHARMDX
2017-03-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX
2017-02-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)
2016-12-01
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX (Non-Squamous Indication)
2016-12-01
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PHARMDX
2016-12-01
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PHARMDX
2016-10-24
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)
2016-10-05
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION)
2016-10-05
DAKO NORTH AMERICA, INC.
PD-L1 IHC 22C3 PHARMDX
2016-09-23
DAKO NORTH AMERICA, INC.
PD-L1 IHC 28-8 pharmDx
2016-01-23
DAKO NORTH AMERICA, INC.

48 records. Showing 1-40. Next

PMN#

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 EPI
2013-02-12
DAKO NORTH AMERICA, INC.
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
2009-05-08
DAKO NORTH AMERICA, INC.

GUDID#

User-Fillable Reagent Bottle 5mL Capacity (Link) - SK200
Dako North America, Inc.
2020-09-17
User-Fillable Reagent Bottle 12mL Capacity (Link) - SK201
Dako North America, Inc.
2020-09-17
User-Fillable Reagent Bottle 25mL Capacity (Link) - SK202
Dako North America, Inc.
2020-09-17
User-Fillable Reagent Bottle 50mL Capacity (Link) - SK203
Dako North America, Inc.
2020-09-17
Fragile X Fluorescein-Labelled Probe - Y1442
Dako North America, Inc.
2020-09-17