Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014456004

FEI Number

3014456004

Entity Name

PRENOSIS, INC.

City/State/Country

Chicago, IL, US

Establishment Address

3440 S Dearborn St, Suite 216S, Chicago, IL 60616, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Prenosis, Inc. (Owner Number: 10091847)

Owner / Operator Contact Address

3440 S Dearborn St, Suite 216S, Chicago, IL 60616, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN230036

PMA Number

N/A

All Registered Proprietary Names

Sepsis ImmunoScore

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SAK	Software Device To Aid In The Prediction Or Diagnosis Of Sepsis	General Hospital	Class 2	880.6316	2024-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prenosis, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014456004. Last updated year: 2026. Please use registration number 3014456004 when referencing this establishment in official correspondence.