Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016531205

FEI Number

3016531205

Entity Name

FLUXERGY INC.

City/State/Country

Irvine, CA, US

Establishment Address

15 Musick, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

FLUXERGY INC. (Owner Number: 10081367)

Owner / Operator Contact Address

15 MUSICK, Irvine, CA 92618, 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
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-04-07

Official Correspondent

CUONG (NICK) TRAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FLUXERGY INC.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016531205. Last updated year: 2026. Please use registration number 3016531205 when referencing this establishment in official correspondence.