Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013841562

FEI Number

3013841562

Entity Name

Exact Sciences Corporation- Legacy Campus

City/State/Country

Madison, WI, US

Establishment Address

320 Holtzman Road, Madison, WI 53713, 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

Capture Aspirator Capture Incubator 2 Capture Incubator Sample Mixer Sample Mixer 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2017-07-12
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2017-02-08
JRO	Blender/Mixer	Clinical Chemistry	Class 1	862.2050	2014-08-18

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
3015728010	Exact Sciences Corporation- Discovery 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013841562. Last updated year: 2026. Please use registration number 3013841562 when referencing this establishment in official correspondence.