Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005841640

FEI Number

3005841640

Entity Name

DFI CO., LTD.

City/State/Country

Gimhae Jeonnam, KR

Establishment Address

388-25 Gomo-Ro, Jillye-Myeon, Gimhae Jeonnam 50875, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DFI CO., LTD. (Owner Number: 9089171)

Owner / Operator Contact Address

388-25, Gomo-Ro, Jillye-myeon, --, Gimhae-Si, KR-44 621-881, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052525

PMA Number

N/A

All Registered Proprietary Names

QTEST 11 CYBOW 10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2006-06-28
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2006-06-28
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2006-06-28
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2006-06-28
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2006-06-28
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2006-06-28
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2006-06-28
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2006-06-28
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2006-06-28
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2006-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

DFI CO., LTD.

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
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.

Similar Registrations

Registration Number	Establishment Name	Location
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US
3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN
3024171133	Changchun LYZ Technology Co.,LTD	Changchun City Jilin, CN
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005841640. Last updated year: 2026. Please use registration number 3005841640 when referencing this establishment in official correspondence.