Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1119189

FEI Number

1119189

Entity Name

LKC TECHNOLOGIES, INC.

City/State/Country

Germantown, MD, US

Establishment Address

20501 Seneca Meadows Pkwy Ste 305, Germantown, MD 20876, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LKC TECHNOLOGIES, INC. (Owner Number: 1119189)

Owner / Operator Contact Address

20501 Seneca Meadows Parkway, Suite 305, Germantown, MD 20876, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K820414

PMA Number

N/A

All Registered Proprietary Names

RETeval; RETeval Complete; RETeval Flicker; RETeval Sensor Strips EPIC UTAS SG-2002 UTAS-E3000 MGS-2 UTAS BigShot EPIC-4000 UTAS-E4000 UTAS-E3000mf UTAS SunBurst CMGS-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2015-05-20
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	1992-06-25

Official Correspondent

Dina Dubey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LKC TECHNOLOGIES, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1119189. Last updated year: 2026. Please use registration number 1119189 when referencing this establishment in official correspondence.