Exact Sciences Corporation- Innovation Campus

FDA Device Registration & Listing · Madison, WI, US · Registration 3008256118

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008256118
FEI Number
3008256118
Entity Name
Exact Sciences Corporation- Innovation Campus
City/State/Country
Madison, WI, US
Establishment Address
441 Charmany Dr, Madison, WI 53719, 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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P130017

All Registered Proprietary Names

Conversion Wash 2 (Concentrate) Capture Aspirator Cologuard Plus Cologuard

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPM General Purpose Reagent Pathology Class 1 864.4010 2024-07-16
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2017-07-12
PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection Unknown Class 3 N/A 2025-02-12
PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection Unknown Class 3 N/A 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
3013841562 Exact Sciences Corporation- Legacy 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 3008256118. Last updated year: 2026. Please use registration number 3008256118 when referencing this establishment in official correspondence.
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