Exact Sciences Corp

FDA Filings

This page includes the latest FDA filings for Exact Sciences Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQEXASDUNS 150908853
FDA Registration(s)
Registration Number3008256118
FEI Number3008256118
NameExact Sciences Corporation
Owner & OperatorExact Sciences Corp
Contact Address441 Charmany Drive
Madison WI 53719 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address441 Charmany Dr
Madison, WI 53719 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



Registration Number3013841562
FEI Number3013841562
NameEXACT SCIENCES CORP
Owner & OperatorExact Sciences Corp
Contact Address441 Charmany Drive
Madison WI 53719 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address320 Holtzman Road
Madison, WI 53713 US
Establishment TypeManufacture Medical Device



Registration Number3015728010
FEI Number3015728010
NameExact Sciences, Corporation
Owner & OperatorExact Sciences Corp
Contact Address441 Charmany Drive
Madison WI 53719 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address650 Forward Dr
Madison, WI 53711 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Exact Sciences Corporation
Cologuard2020-06-15
Exact Sciences Corporation
Cologuard2020-05-12
Exact Sciences Corporation
Cologuard2020-04-13
Exact Sciences Corporation
Cologuard2020-03-12
EXACT SCIENCES CORPORATION
Cologuard Capture Wash Kit 2019-12-10
EXACT SCIENCES CORPORATION
Cologuard Inhibitor Removal Tablet Kit 2019-12-10
EXACT SCIENCES CORPORATION
Cologuard Binding Solution Kit 2019-12-10
EXACT SCIENCES CORPORATION
Cologuard Spin Filter Kit 2019-12-10
EXACT SCIENCES CORPORATION
STARlet Interface 2019-11-12
EXACT SCIENCES CORPORATION
Analytical Client 2019-11-12
EXACT SCIENCES CORPORATION
Analytical Server 2019-11-12
EXACT SCIENCES CORPORATION
Cologuard Test Definition v1.4 2019-11-12
EXACT SCIENCES CORPORATION
Cycler Control 2019-11-12
Exact Sciences Corporation
COLOGUARD2019-10-24
Exact Sciences Corporation
Cologuard2019-10-22
Exact Sciences Corporation
Cologaurd2019-10-08
Exact Sciences Corporation
Cologuard2019-09-06
EXACT SCIENCES CORPORATION
Cologuard Test Definition v1.3 2019-07-31
Exact Sciences Corporation
Cologuard2019-06-13
Exact Sciences Corporation
Cologuard Stool DNA-Based Colorectal Cancer Screening Test2019-05-16
Exact Sciences Corporation
Cologuard2019-03-19
Exact Sciences Corporation
COLOGUARD2019-03-11
Exact Sciences Corporation
Cologuard2019-02-20
Exact Sciences Corporation
Cologuard2018-10-29
Exact Sciences Corporation
Cologuard2018-08-24
EXACT SCIENCES CORPORATION
Cologuard Hemoglobin Bead Based Dilution Buffer Kit 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Hemoglobin Bead Based Assay Wash 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Hemoglobin Bead Based Assay Reagents Kit 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Hemoglobin Bead Based Control Kit 2018-07-06
EXACT SCIENCES CORPORATION
Home Page 2018-07-06
EXACT SCIENCES CORPORATION
Reader Control 2018-07-06
EXACT SCIENCES CORPORATION
STARlet Interface 2018-07-06
EXACT SCIENCES CORPORATION
Analytical Server 2018-07-06
EXACT SCIENCES CORPORATION
Analytical Client 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Stool Buffer 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Stool Buffer 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Hemoglobin Assay Wash 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Capture Bead Pre-Wash 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Conversion Wash 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Binding Solution 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Capture Wash 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Capture Solution 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Spin Filter 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Barcoded Mixing Tubes 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Inhibitor Removal Tablet 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard DNA Control Kit 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Hemoglobin Control Kit 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Hemoglobin Assay Reagents 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard QuARTS Assay Reagents 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard DNA Preparation Reagent 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard Collection Kit 2018-07-06
EXACT SCIENCES CORPORATION
Cologuard DNA Capture Reagents 2018-07-06
Exact Sciences Corporation
Cologuard2018-03-07
Exact Sciences Corporation
Cologuard2017-12-18
Exact Sciences Corporation
Cologuard2017-11-06
Exact Sciences Corporation
Cologuard2017-08-08
Exact Sciences, Corporation [Exact Sciences Corp]
Capture Aspirator2017-07-12
Exact Sciences Corporation [Exact Sciences Corp]
Capture Aspirator2017-07-12
EXACT SCIENCES CORP
Capture Aspirator2017-07-12
Exact Sciences Corporation
Cologuard2017-06-30
Exact Sciences Corporation
Cologuard2017-06-23
Exact Sciences Corporation
Cologuard2017-05-24
Exact Sciences Corporation
COLOGUARD2017-05-17
Exact Sciences, Corporation [Exact Sciences Corp]
Capture Incubator2017-02-08
Exact Sciences, Corporation [Exact Sciences Corp]
Capture Incubator 22017-02-08
Exact Sciences Corporation [Exact Sciences Corp]
Capture Incubator2017-02-08
Exact Sciences Corporation [Exact Sciences Corp]
Capture Incubator 22017-02-08
EXACT SCIENCES CORP
Capture Incubator2017-02-08
EXACT SCIENCES CORP
Capture Incubator 22017-02-08
Exact Sciences Corporation
COLOGUARD2016-12-13
Exact Sciences Corporation
COLOGUARD2016-12-01
Exact Sciences Corporation
COLOGUARD2016-11-17
Exact Sciences Corporation
COLOGUARD2016-08-19
Exact Sciences Corporation
COLOGUARD2016-07-26
Exact Sciences Corporation
COLOGUARD2016-05-05
Exact Sciences Corporation
COLOGUARD2016-05-03
Exact Sciences Corporation
COLOGUARD2016-04-20
Exact Sciences Corporation
COLOGUARD2016-02-04
Exact Sciences Corporation
COLOGUARD2015-12-23
Exact Sciences Corporation
COLOGUARD2015-09-25
Exact Sciences Corporation
COLOGUARD2015-08-19
Exact Sciences Corporation
COLOGUARD2015-08-18
Exact Sciences Corporation
COLOGUARD2015-02-02
Exact Sciences Corporation [Exact Sciences Corp]
Cologuard2014-08-18
EXACT SCIENCES CORP
Cologuard2014-08-18
Exact Sciences, Corporation [Exact Sciences Corp]
Sample Mixer2014-08-18
Exact Sciences, Corporation [Exact Sciences Corp]
Sample Mixer 22014-08-18
Exact Sciences Corporation [Exact Sciences Corp]
Sample Mixer2014-08-18
Exact Sciences Corporation [Exact Sciences Corp]
Sample Mixer 22014-08-18
EXACT SCIENCES CORP
Sample Mixer2014-08-18
EXACT SCIENCES CORP
Sample Mixer 22014-08-18
Exact Sciences Corporation
COLOGUARD2014-08-11

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