Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015728010

FEI Number

3015728010

Entity Name

Exact Sciences Corporation- Discovery Campus

City/State/Country

Madison, WI, US

Establishment Address

650 Forward Dr, Madison, WI 53711, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Exact Sciences Corporation (Owner Number: 10047364)

Owner / Operator Contact Address

5505 Endeavor Lane, Madison, WI 53719, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cologuard Capture Aspirator Sample Mixer Sample Mixer 2 Conversion Wash 2 (Concentrate)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Unknown	Class 3	N/A	2014-08-18
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2017-07-12
JRO	Blender/Mixer	Clinical Chemistry	Class 1	862.2050	2014-08-18
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2024-07-16

Official Correspondent

Ashlie Rodriguez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exact Sciences Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008256118	Exact Sciences Corporation- Innovation Campus	Madison, WI, US
3013841562	Exact Sciences Corporation- Legacy Campus	Madison, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Similar Registrations

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3032518803	NEW DAY DIAGNOSTICS	Knoxville, TN, US
1938173	SIGMA-ALDRICH MANUFACTURING, LLC	ST. LOUIS, MO, US
3011397539	Molex Little Rock	Maumelle, AR, US
9681753	SENTINEL CH. SPA	MILANO, IT
2134944	PHILLIPS-MEDISIZE, LLC	New Richmond, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015728010. Last updated year: 2026. Please use registration number 3015728010 when referencing this establishment in official correspondence.