Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021179642

FEI Number

3021179642

Entity Name

NEELYX LABS

City/State/Country

Wood Dale, IL, US

Establishment Address

330 Georgetown Sq, Wood Dale, IL 60191, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Neelyx Labs, Inc (Owner Number: 10084878)

Owner / Operator Contact Address

330 Georgetown Square, Unit 104, Wood Dale, IL 60191, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2024-01-04

Official Correspondent

Shyam Saladi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neelyx Labs, 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 3021179642. Last updated year: 2026. Please use registration number 3021179642 when referencing this establishment in official correspondence.